CompletedPhase 3

Management of Post-Tonsillectomy Pain in Pediatric Patients

United States50 participantsStarted 2020-09-28

Plain-language 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.

Who can participate

Age range4 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3

Timeframe: up to 3 days following consent

Trial details

NCT IDNCT04551196

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-10

Results submitted2023-11-27

View on ClinicalTrials.gov More Pain, Postoperative trials