Management of Post-Tonsillectomy Pain in Pediatric Patients

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• 4 to 17 years of age at time of enrollment

• Undergoing tonsillectomy with or without adenoidectomy

• Able to provide informed consent from parent or legal guardian

• Able to provide assent if subject is a minor of appropriate age

Exclusion Criteria:

• Allergy to acetaminophen or ibuprofen

• Inability for study participant to cooperate with pain assessments

• Known pregnancy

• Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study