Trial Outcomes & Findings for Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy (NCT NCT01605903)

Results Overview

Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

741 participants

Primary outcome timeframe

Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.

Results posted on

2018-04-24

Participant Flow

741 patients were enrolled between May 3, 2012 and January 20, 2017 at participating institutions (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center San Diego, San Diego; Naval Medical Center Portsmouth, Portsmouth; and Madigan Army Medical Center, Tacoma) prior to surgery.

All enrolled subjects were randomized to a treatment group, however 53 (7.2%) patients did not receive the study medication , either because they dropped out prior to the first dose of study medication, the procedure was cancelled, alternative surgical technique was used, pharmacy error, or IV acetaminophen was administered.

Participant milestones

Participant milestones
Measure	Treatment With Ibuprofen Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.	Treatment With Acetaminophen Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
Overall Study STARTED	345	343
Overall Study COMPLETED	345	343
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Ibuprofen n=345 Participants Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6. Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.	Treatment With Acetaminophen n=343 Participants Children will be randomly assigned to either the treatment arm or active comparator prior to surgery. Children in the active comparator group (Acetaminophen) will receive grape flavored 160 mg/5 ml acetaminophen. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6. Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.	Total n=688 Participants Total of all reporting groups
Age, Continuous	5 years n=345 Participants	5 years n=343 Participants	5 years n=688 Participants
Sex: Female, Male Female	168 Participants n=345 Participants	154 Participants n=343 Participants	322 Participants n=688 Participants
Sex: Female, Male Male	177 Participants n=345 Participants	189 Participants n=343 Participants	366 Participants n=688 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.

Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.

Outcome measures

Outcome measures
Measure	Treatment With Ibuprofen n=345 Participants Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.	Treatment With Acetaminophen n=343 Participants Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
Number of Participants With Level 3 Postoperative Hemorrhage	10 Participants	4 Participants

Adverse Events

Treatment With Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment With Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gillian Diercks, MD, MPH

Massachusetts Eye and Ear Infirmar

Phone: 617-573-3190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place