CompletedPhase 2

A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

United States10 participantsStarted 2019-08-02

Plain-language summary

This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.

Who can participate

Age range4 Years – 8 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

✓. Patients undergoing adenoidectomy ± bilateral ear tube placement
✓. Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations

Exclusion criteria

✕. An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
✕. A known hypersensitivity or allergy to any of the study medications;
✕. A history of chronic opioid use prior to surgery;
✕. Coexisting renal or hepatic disease;
✕. Morbid obesity (BMI% ≥ 99).

What they're measuring

Average Pain Score

Timeframe: 1 hr post-op

Trial details

NCT IDNCT03714919

SponsorArlyne Thung

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-10

Results submitted2020-12-04

View on ClinicalTrials.gov More Adenoid Hypertrophy trials