Trial Outcomes & Findings for Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy (NCT NCT04791761)
NCT ID: NCT04791761
Last Updated: 2024-08-30
Results Overview
Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of these pain ratings will be the primary outcome measure.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
14 days post-operatively
Results posted on
2024-08-30
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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Opioid Pain Control + Disposal Pouch
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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.
|
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 or by email/mail if no appointment was scheduled.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
16
|
36
|
|
Overall Study
COMPLETED
|
13
|
8
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
12
|
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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Opioid Pain Control + Disposal Pouch
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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.
|
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 or by email/mail if no appointment was scheduled.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy
Baseline characteristics by cohort
| Measure |
Opioid Pain Control
n=21 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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Opioid Pain Control + Disposal Pouch
n=15 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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.
|
Non-opioid Pain Control
n=35 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 or by email/mail if no appointment was scheduled.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
4 years
n=5 Participants
|
4 years
n=7 Participants
|
4 years
n=5 Participants
|
4 years
n=4 Participants
|
|
Age, Customized
3-7 years old
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Age, Customized
8-12 years old
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Customized
13-17 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
35 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
BMI Centile
|
72.31 percentile
n=5 Participants
|
63.37 percentile
n=7 Participants
|
72.50 percentile
n=5 Participants
|
69.48 percentile
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days post-operativelyPopulation: Includes only patients who returned their pain diary (completed the study). Both those who did and did not receive the drug disposal bag are included in the opioid group, since this factor is not relevant to pain control. One patient in the opioid group reported no post-medication pain scores.
Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of these pain ratings will be the primary outcome measure.
Outcome measures
| Measure |
Opioid Pain Control
n=21 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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Non-opioid Pain Control
n=24 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 or by email/mail if no appointment was scheduled.
|
|---|---|---|
|
Average Pain Burden
Before Medications
|
3.2 score on a scale
Interval 2.5 to 3.8
|
3.3 score on a scale
Interval 2.6 to 4.1
|
|
Average Pain Burden
After Medications
|
1.1 score on a scale
Interval 0.6 to 1.5
|
1.1 score on a scale
Interval 0.6 to 1.5
|
SECONDARY outcome
Timeframe: 14 days post-operativelyPopulation: Both those who did and did not receive the drug disposal bag are included in the opioid group, since this factor is not relevant to visiting the emergency room or urgent care. Excludes patients withdrawn due to protocol violations.
Number of 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
n=36 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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Non-opioid Pain Control
n=35 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 or by email/mail if no appointment was scheduled.
|
|---|---|---|
|
ED (Emergency Department) or Urgent Care Visits
0 ED or Urgent Care Visits
|
36 Participants
|
33 Participants
|
|
ED (Emergency Department) or Urgent Care Visits
1 ED or Urgent Care Visit
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyNumber of hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyIn the take-home pain diary, patients will place an 'x' on each time block every day that medication was given for each of the three medications. The frequencies will be summed for a total number and averaged within each group to determine the average number of times of each analgesic used.
Outcome measures
Outcome data not reported
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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyScore assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a 5-point Likert scale of 0 (strongly disagree) to 4 (strongly agree). 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 and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores indicate a better outcome.
Outcome measures
Outcome data not reported
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
Outcome data not reported
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
Outcome data not reported
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
Outcome data not reported
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
Outcome data not reported
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
Outcome data not reported
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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days post-operativelyNumber 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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up until the return of the pain diary within 8 weeks of the surgeryNumber of patients who reported that they used the opioid disposal pouch on the last page of the pain diary
Outcome measures
Outcome data not reported
Adverse Events
Opioid Pain Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Opioid Pain Control + Disposal Pouch
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-opioid Pain Control
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opioid Pain Control
n=21 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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Opioid Pain Control + Disposal Pouch
n=16 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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.
|
Non-opioid Pain Control
n=36 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 or by email/mail if no appointment was scheduled.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post-Tonsillectomy Hemorrhage Requiring Hospital Admission
|
0.00%
0/21 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
2.8%
1/36 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
Other adverse events
| Measure |
Opioid Pain Control
n=21 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. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. The diary will be completed by post-operative day 14. Families will receive an opioid disposal education document.
|
Opioid Pain Control + Disposal Pouch
n=16 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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.
|
Non-opioid Pain Control
n=36 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 or by email/mail if no appointment was scheduled.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post-Tonsillectomy Hemorrhage Not Requiring Hospital Admission
|
4.8%
1/21 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/36 • 5-9 weeks depending on the date of the follow-up appointment
|
|
Metabolism and nutrition disorders
Decreased Oral Intake
|
0.00%
0/21 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
5.6%
2/36 • Number of events 2 • 5-9 weeks depending on the date of the follow-up appointment
|
|
General disorders
Fever
|
0.00%
0/21 • 5-9 weeks depending on the date of the follow-up appointment
|
6.2%
1/16 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/36 • 5-9 weeks depending on the date of the follow-up appointment
|
|
Gastrointestinal disorders
Emesis
|
4.8%
1/21 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
2.8%
1/36 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/36 • 5-9 weeks depending on the date of the follow-up appointment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
2.8%
1/36 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
|
General disorders
Eye/Cheek Edema
|
4.8%
1/21 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/16 • 5-9 weeks depending on the date of the follow-up appointment
|
0.00%
0/36 • 5-9 weeks depending on the date of the follow-up appointment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place