Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Recruiting
Phase 4
Interventional Study
Pain, Postoperative
Tonsillar Hypertrophy
Tonsillitis
Pediatric Sleep Apnea
Sleep-Disordered Breathing
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 – 17
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 440 (estimated)
- Sponsor
- Duke University · Other
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About This Trial
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \>= 3 and \< 18 years
2. Elective tonsillectomy +/- adenoidectomy
3. Signed informed consent by parent or legal guardian
4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
5. Negative pregnancy test within 48 hour…
Contacts