Trial Outcomes & Findings for Non-opioids for Analgesia After Adenotonsillectomy in Children (NCT NCT03618823)
NCT ID: NCT03618823
Last Updated: 2021-11-10
Results Overview
Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
268 participants
Primary outcome timeframe
14 days post-operatively
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
Opioid Pain Control
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
136
|
|
Overall Study
COMPLETED
|
69
|
75
|
|
Overall Study
NOT COMPLETED
|
63
|
61
|
Reasons for withdrawal
| Measure |
Opioid Pain Control
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
63
|
61
|
Baseline Characteristics
Non-opioids for Analgesia After Adenotonsillectomy in Children
Baseline characteristics by cohort
| Measure |
Opioid Pain Control
n=132 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control
n=136 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.39 Years
STANDARD_DEVIATION 3.33 • n=5 Participants
|
8.15 Years
STANDARD_DEVIATION 3.33 • n=7 Participants
|
8.27 Years
STANDARD_DEVIATION 3.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
BMI Centile
|
66.42 Percentage
STANDARD_DEVIATION 32.81 • n=5 Participants
|
67.20 Percentage
STANDARD_DEVIATION 31.44 • n=7 Participants
|
66.81 Percentage
STANDARD_DEVIATION 32.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days post-operativelyPopulation: Participants were analyzed for average pain burden if they completed the take-home pain diary and pain scores were recorded.
Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain.
Outcome measures
| Measure |
Opioid Pain Control Group
n=60 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=68 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Average Pain Burden
Before
|
5.78 Score on a scale
Standard Error 0.25
|
5.66 Score on a scale
Standard Error 0.23
|
|
Average Pain Burden
After
|
2.33 Score on a scale
Standard Error 0.22
|
2.24 Score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 14 days post-operativelyNumber of participants with emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Number of Participants With ED (Emergency Department) or Urgent Care Visits
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 14 days post-operativelyPopulation: Participants were analyzed for side effects of medications if they completed the take-home pain diary and side effects of medications were recorded.
Number of any of the following side effects experienced: Nausea, vomiting, constipation, stomach ache, difficulty breathing. Assessed at follow-up and take-home pain diary.
Outcome measures
| Measure |
Opioid Pain Control Group
n=65 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=66 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Number of Side Effects of Medications
0 side effect
|
38 Participants
|
35 Participants
|
|
Number of Side Effects of Medications
1 side effect
|
10 Participants
|
22 Participants
|
|
Number of Side Effects of Medications
2 side effect
|
7 Participants
|
7 Participants
|
|
Number of Side Effects of Medications
3 side effect
|
9 Participants
|
2 Participants
|
|
Number of Side Effects of Medications
4 side effect
|
1 Participants
|
0 Participants
|
|
Number of Side Effects of Medications
5 side effect
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyNumber of participants with hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Number of Participants With Readmissions
|
3 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyPopulation: Participants who took mg dose instead of ml for acetaminophen and ibuprofen were taken out of the analysis.
In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used.
Outcome measures
| Measure |
Opioid Pain Control Group
n=61 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=67 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Average Dose of Each Analgesic Used
Acetaminophen
|
6.54 Milliliters
Standard Deviation 2.87
|
7.52 Milliliters
Standard Deviation 6.47
|
|
Average Dose of Each Analgesic Used
Ibuprofen
|
7.53 Milliliters
Standard Deviation 4.08
|
7.53 Milliliters
Standard Deviation 4.74
|
|
Average Dose of Each Analgesic Used
Oxycodone
|
0.13 Milliliters
Standard Deviation 0.19
|
0.04 Milliliters
Standard Deviation 0.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyUsing the results of the take-home pain diary, we will calculate the average number of days of use of each analgesic for each group. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Duration of Each Analgesic Used
Acetaminophen
|
8.61 days
Standard Deviation 2.97
|
8.64 days
Standard Deviation 3.40
|
|
Duration of Each Analgesic Used
Ibuprofen
|
8.49 days
Standard Deviation 3.42
|
8.75 days
Standard Deviation 3.46
|
|
Duration of Each Analgesic Used
Oxycodone
|
2.62 days
Standard Deviation 2.90
|
0.45 days
Standard Deviation 1.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyPopulation: Participants who took mg dose instead of ml for acetaminophen and ibuprofen were taken out of the analysis.
Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported.
Outcome measures
| Measure |
Opioid Pain Control Group
n=61 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=67 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Mean of Total Quantity of Pain Medications Taken
Acetaminophen
|
292.48 Milliliters
Standard Deviation 178.73
|
326.98 Milliliters
Standard Deviation 269.66
|
|
Mean of Total Quantity of Pain Medications Taken
Ibuprofen
|
324.14 Milliliters
Standard Deviation 225.70
|
334.65 Milliliters
Standard Deviation 234.18
|
|
Mean of Total Quantity of Pain Medications Taken
Oxycodone
|
6.47 Milliliters
Standard Deviation 9.89
|
2.96 Milliliters
Standard Deviation 14.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyPopulation: Participants were analyzed for overall pain relief satisfaction if they completed the take-home pain diary and overall pain relief satisfaction was recorded.
Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. Patients will respond to the following statement "I am happy with the pain relief I received in the last 14 days" with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value, from 0 (strongly disagree) to 4 (strongly agree), and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores mean a better outcome.
Outcome measures
| Measure |
Opioid Pain Control Group
n=63 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=64 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Overall Pain Relief Satisfaction
|
3.35 score on a scale
Standard Deviation 0.79
|
3.09 score on a scale
Standard Deviation 0.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyNumber of post-operative phone calls to nursing staff, obtained using the electronic medical record.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Post-operative Nursing Phone Calls
|
0.35 post-operative phone calls
Standard Deviation 0.66
|
0.47 post-operative phone calls
Standard Deviation 0.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyNumber of night-time awakenings reported in 14 days - assessed via the take-home pain diary.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Number of Night-time Awakenings
None
|
10 Participants
|
13 Participants
|
|
Number of Night-time Awakenings
Some nights (1-4)
|
33 Participants
|
28 Participants
|
|
Number of Night-time Awakenings
Many nights (5-9)
|
19 Participants
|
18 Participants
|
|
Number of Night-time Awakenings
Most nights (10-14)
|
3 Participants
|
7 Participants
|
|
Number of Night-time Awakenings
No response
|
4 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyNumber of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary.
Outcome measures
| Measure |
Opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Non-opioid Group Switching to Opioid Group
|
7 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: two months post-operativelyDoes the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Need for Follow-up Appointment
No response
|
7 Participants
|
11 Participants
|
|
Need for Follow-up Appointment
No
|
54 Participants
|
49 Participants
|
|
Need for Follow-up Appointment
Yes
|
8 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyTotal household income ranges will be assessed in the take-home pain diary and reported.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Household Income
$75,001-100,000
|
11 Participants
|
9 Participants
|
|
Household Income
$100,001-125,000
|
9 Participants
|
6 Participants
|
|
Household Income
$125,001-150,000
|
3 Participants
|
3 Participants
|
|
Household Income
$150,001-175,000
|
1 Participants
|
1 Participants
|
|
Household Income
$175,001-200,000
|
7 Participants
|
5 Participants
|
|
Household Income
$200,000 or more
|
2 Participants
|
2 Participants
|
|
Household Income
Prefer not to answer
|
3 Participants
|
11 Participants
|
|
Household Income
No response
|
14 Participants
|
13 Participants
|
|
Household Income
$0-25,000
|
2 Participants
|
7 Participants
|
|
Household Income
$25,001-50,000
|
8 Participants
|
7 Participants
|
|
Household Income
$50,001-75,000
|
9 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyUsing the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household.
Outcome measures
| Measure |
Opioid Pain Control Group
n=69 Participants
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control Group
n=75 Participants
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Education Level
No response
|
14 Participants
|
13 Participants
|
|
Education Level
Some high school
|
0 Participants
|
3 Participants
|
|
Education Level
High school degree
|
4 Participants
|
8 Participants
|
|
Education Level
Vocational or associate degree
|
7 Participants
|
10 Participants
|
|
Education Level
Some college
|
7 Participants
|
4 Participants
|
|
Education Level
College degree
|
18 Participants
|
24 Participants
|
|
Education Level
Master's degree
|
14 Participants
|
9 Participants
|
|
Education Level
Professional or academic doctorate
|
4 Participants
|
3 Participants
|
|
Education Level
Prefer not to answer
|
1 Participants
|
1 Participants
|
Adverse Events
Opioid Pain Control
Serious events: 9 serious events
Other events: 38 other events
Deaths: 0 deaths
Non-opioid Pain Control
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opioid Pain Control
n=149 participants at risk
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
Non-opioid Pain Control
n=119 participants at risk
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
|
|---|---|---|
|
Surgical and medical procedures
Post-Tonsillectomy Hemorrhage Requiring Operative Intervention
|
4.7%
7/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
2.5%
3/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
|
General disorders
Dehydration Requiring Inpatient Admission
|
1.3%
2/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
0.00%
0/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen Desaturation
|
0.00%
0/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
0.84%
1/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
Other adverse events
| Measure |
Opioid Pain Control
n=149 participants at risk
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
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Non-opioid Pain Control
n=119 participants at risk
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours.
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|---|---|---|
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Vascular disorders
Post-Tonsillectomy Hemorrhage Not Requiring Operative Intervention
|
8.7%
13/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
6.7%
8/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
|
General disorders
Emergency Department Visit for Pain
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5.4%
8/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
0.00%
0/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
|
General disorders
Nursing Phone Call for Pain
|
15.4%
23/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
12.6%
15/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
|
General disorders
Nausea or Vomiting
|
6.7%
10/149 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
|
2.5%
3/119 • 5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment. 17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request. The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid). The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
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Additional Information
Senior Research Associate
UPMC Children's Hospital of Pittsbugh
Phone: 1412-692-9879
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place