NCT01605903

Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy

Completed Phase 2 Results posted Last updated 24 April 2018

What this trial tests

Phase 2 trial testing Ibuprofen in Tonsillectomy in 741 participants. Completed in 15 February 2017.

Timeline

3 May 2012

Primary endpoint
15 February 2017

15 February 2017

Quick facts

Lead sponsor	Massachusetts Eye and Ear Infirmary
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	741
Start date	3 May 2012
Primary completion	15 February 2017
Estimated completion	15 February 2017
Sites	5 locations across United States

Drugs / interventions tested

• Ibuprofen (ibuprofen) — full drug profile →
• Acetaminophen (Paracetamol) — full drug profile →

Conditions studied

• Tonsillectomy — all drugs for Tonsillectomy →
• Adenoidectomy — all drugs for Adenoidectomy →

Sponsor

Massachusetts Eye and Ear Infirmary — full company profile →

Who can join

Adults 2 to 18, any sex, with Tonsillectomy or Adenoidectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Level 3 Postoperative Hemorrhage Primary · 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.

Group	Value	95% CI
Treatment With Ibuprofen	10
Treatment With Acetaminophen	4

Sponsor's own description

Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy.
   Lewis SR, Nicholson A, Cardwell ME, Siviter G, et al · · 2013 · cited 58× · PMID 23881651 · DOI 10.1002/14651858.cd003591.pub3
2. Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.
   Diercks GR, Comins J, Bennett K, Gallagher TQ, et al · · 2019 · cited 38× · PMID 30946442 · DOI 10.1001/jamaoto.2019.0269