Management of Post-Tonsillectomy Pain in Pediatric Patients

Completed · Phase 3

Conditions studied: Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis

In brief

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.

Key facts

Study ID

NCT04551196

Run by

Washington University School of Medicine

People needed

50

Starts

2020-09-28

Expected to finish

2022-11-10

Last updated by the study team

2024-07-11

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saint Louis Children's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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