Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy

Summary

Pediatric tonsillectomy is one of the most common surgical procedures annually in the United States; risks include postoperative hemorrhage and poor pain control. Controversy exists regarding optimal pharmacologic pain management following surgery, as each drug's efficacy is balanced by its specific side effects. Ibuprofen is effective in controlling postoperative pain following tonsillectomy, but its mechanism of action results in decreased platelet function, which may increase postoperative bleeding events. This is a multicenter, randomized control non-inferiority trial designed to assess the relationship between short-course ibuprofen use and post-tonsillectomy bleeding when compared to acetaminophen.

Conditions

• Tonsillectomy With or Without Adenoidectomy

Interventions

DRUG

Ibuprofen

Grape-flavored ibuprofen 100mg/5mL (Leader®) will be dispensed. Ibuprofen will be dosed at 10mg/kg (max dose 600mg) QID (roughly Q6 hours, however we left dosing QID to allow for some flexibility in the dosing schedule to accommodate patient sleeping schedules). The pharmacy will manipulate the volume of each medication using Ora Blend suspension so that for each child, weight-based dosing of each medication will be equivalent in volume. The first dose of study medication will be dispensed 4 hours after the preoperative acetaminophen dose. Thereafter, medication will be dosed QID (or roughly 6 hours apart). Surgeons, nursing staff, and patients and their families will be blinded regarding the type of medication administered.

DRUG

Acetaminophen

Grape-flavored acetaminophen 160mg/5mL (Leader®) will be dispensed based upon the arm to which each participant has been randomized. Acetaminophen at 15mg/kg (max dose 650mg), dosing will be QID (roughly Q6 hours, however we left dosing QID to allow for some flexibility in the dosing schedule to accommodate patient sleeping schedules). The pharmacy will manipulate the volume of each medication using Ora Blend suspension so that for each child, weight-based dosing of each medication will be equivalent in volume. The first dose of study medication will be dispensed 4 hours after the preoperative acetaminophen dose. Thereafter, medication will be dosed QID (or roughly 6 hours apart). Surgeons, nursing staff, and patients and their families will be blinded regarding the type of medication administered.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• Madigan Army Medical Center

  collaborator FED

• United States Naval Medical Center, Portsmouth

  collaborator FED

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Massachusetts Eye and Ear Infirmary

  lead OTHER

Principal Investigators

• Christopher J Hartnick, MD · Massachusetts Eye and Ear

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-30

Primary Completion

2023-01-01

Completion

2023-01-01

FDA Drug

Yes

Countries

• United States

Study Locations