CompletedEarly Phase 1

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

United States189 participantsStarted 2020-02-26

Plain-language summary

A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

Age range2 Years – 15 Years

SexALL

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

✓. Children ages 2 to 15 years old
✓. Presenting for tonsillectomy or adenotonsillectomy surgery
✓. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
✓. Provide Informed Consent / Assent (as appropriate)

✕. Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
✕. Revision tonsillectomy or revision adenotonsillectomy surgery
✕. Known pregnancy
✕. Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.

Number of Patients Requiring Rescue Intravenous Opioid

Timeframe: up to 6 hours post surgery

NCT IDNCT04230681

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-01

Results submitted2023-05-10