Trial Outcomes & Findings for Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity (NCT NCT04879823)

NCT ID: NCT04879823

Last Updated: 2024-09-05

Results Overview

Average pain over 2-8 post-operative days before 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 the pain ratings prior to taking pain medications from post-operative days 2-8 will be the primary outcome measure.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 222 participants
• Primary outcome timeframe: 2-8 days post-operatively
• Results posted on: 2024-09-05

Participant Flow

Participant milestones

Measure	Dexamethasone IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
Overall Study STARTED	110	112
Overall Study COMPLETED	62	73
Overall Study NOT COMPLETED	48	39

Reasons for withdrawal

Measure	Dexamethasone IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
Overall Study Physician Decision	3	1
Overall Study Protocol Violation	2	3
Overall Study Lost to Follow-up	43	35

Baseline Characteristics

Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Baseline characteristics by cohort

Measure	Dexamethasone n=105 Participants IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo n=108 Participants An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Total n=213 Participants Total of all reporting groups
Age, Continuous	7.1 years n=5 Participants	6.9 years n=7 Participants	7.1 years n=5 Participants
Age, Customized 3-7 years old	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Age, Customized 8-12 years old	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Age, Customized 13-17 years old	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	54 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	54 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	102 Participants n=7 Participants	199 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	94 Participants n=7 Participants	185 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants	108 participants n=7 Participants	213 participants n=5 Participants
BMI Percentile at Baseline	81.04 percentile n=5 Participants	83.77 percentile n=7 Participants	83.24 percentile n=5 Participants

PRIMARY outcome

Timeframe: 2-8 days post-operatively

Population: Includes only patients who returned their pain diary (completed the study).

Average pain over 2-8 post-operative days before 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 the pain ratings prior to taking pain medications from post-operative days 2-8 will be the primary outcome measure.

Outcome measures

Measure	Dexamethasone n=62 Participants IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo n=73 Participants An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
Average Pain Over 2-8 Post-operative Days Before Medications	4.2 score on a scale Interval 3.7 to 4.7	4.9 score on a scale Interval 4.4 to 5.4

SECONDARY outcome

Timeframe: 30 days post-operatively

Population: Excludes patients withdrawn due to protocol violations or physician decision.

Number of emergency department or urgent care visits in 30 post-operative days - assessed via the electronic medical record and the take-home pain diary.

Outcome measures

Measure	Dexamethasone n=105 Participants IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo n=108 Participants An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
ED (Emergency Department) or Urgent Care Visits 0 ED or Urgent Care Visits	97 Participants	91 Participants
ED (Emergency Department) or Urgent Care Visits 1 ED or Urgent Care Visit	5 Participants	14 Participants
ED (Emergency Department) or Urgent Care Visits 2 ED or Urgent Care Visits	3 Participants	2 Participants
ED (Emergency Department) or Urgent Care Visits 3 ED or Urgent Care Visits	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2-8 days post-operatively

Population: Includes only patients who returned their pain diary (completed the study). One patient in the placebo group reported no post-medication pain scores.

Average pain over 2-8 post-operative days 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 the pain ratings one hour after talking pain medications from post-operative days 2-8 will be a secondary outcome measure.

Outcome measures

Measure	Dexamethasone n=62 Participants IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo n=72 Participants An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
Average Pain Burden Post-medication	2.3 score on a scale Interval 0.0 to 8.0	2.2 score on a scale Interval 0.0 to 7.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days post-operatively

Number of hospitalizations after discharge in 30 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-operatively

In 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-operatively

Using the results of the take-home pain diary, the average number of days of use of each analgesic for each group will be calculated. 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-operatively

Score 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-operatively

Number of requests for opioid medication in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days post-operatively

Number of post-operative oropharyngeal bleeds in 30 post-operative days - assessed via the electronic medical record.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Two months post-operatively

Does 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-operatively

Total 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-operatively

Using 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-operatively

Number of side effects assessed daily including bleeding from mouth or throat, anxiety, difficulty breathing, nausea or vomiting, stomach pain/discomfort, fever (100.4F and higher)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days post-operatively

Number 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: 30 days post-operatively

Number of post-operative phone calls to nursing staff, obtained using the electronic medical record up to 30 days post-operatively.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days post-operatively

Number of days in the hospital after surgery in 30 post-operative days - assessed via the electronic medical record

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone n=105 participants at risk IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo n=108 participants at risk An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
Injury, poisoning and procedural complications Post-Tonsillectomy Hemorrhage Requiring Operative Intervention	0.95% 1/105 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	2.8% 3/108 • Number of events 4 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.
Injury, poisoning and procedural complications Post-Tonsillectomy Hemorrhage with Inpatient Admission but Not Requiring Operative Intervention	0.95% 1/105 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	3.7% 4/108 • Number of events 4 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.
Metabolism and nutrition disorders Dehydration Requiring Inpatient Admission	1.9% 2/105 • Number of events 2 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	1.9% 2/108 • Number of events 2 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.

Other adverse events

Measure	Dexamethasone n=105 participants at risk IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.	Placebo n=108 participants at risk An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup. Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.
Injury, poisoning and procedural complications Post-Tonsillectomy Hemorrhage Requiring Neither Operative Intervention nor Inpatient Admission	0.95% 1/105 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	0.00% 0/108 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.
General disorders Emergency Department Visit for Post-Operative Pain	0.95% 1/105 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	7.4% 8/108 • Number of events 8 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.
Gastrointestinal disorders Emergency Department Visit for Post-Operative Nausea or Vomiting	2.9% 3/105 • Number of events 3 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	1.9% 2/108 • Number of events 2 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.
Infections and infestations Surgical Site Infection	0.95% 1/105 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.	0.93% 1/108 • Number of events 1 • 5-9 weeks depending on the date of the follow-up appointment Number at risk excludes patients withdrawn due to protocol violations or physician decision. These patients were instructed not to administer any study medication. One of these patients had surgery cancelled after consent was obtained.

Additional Information

Dr. Amber Shaffer

UPMC Children's Hospital of Pittsburgh

Phone: 4126926874

Email: shafferad@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place