Phase 2
N=66
Pediatric Pain Optimization After Tonsillectomy
Obstructive Sleep Apnea · Tonsillitis · Pain, Procedural
Bottom Line
View on ClinicalTrials.gov: NCT05244226 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Oct 2024
Primary outcome: Primary: Total Amount of Opioid Medications Administered — 1.5; 0.9; 0.5 morphine mg equivalents/kg — p=0.045
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fentanyl/Hydromorphone (Drug); Methadone (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Amount of Opioid Medications Administered |
1.5; 0.9; 0.5 | 0.045 sig |
| SECONDARY Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain |
57; 61; 63 | — |
| SECONDARY NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale |
2.4; 2.2; 2.3 | — |
| SECONDARY Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale |
4.0; 3.7; 3.8 | — |
| SECONDARY Doses of Prescription Opioid Used Following Hospital Discharge |
4; 2; 3 | 0.144 |
| SECONDARY Opioid Administration in the PACU (Post-anesthesia Care Unit) |
0.15; 0.04; 0 | 0.061 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Children ages 3 to 17 years old
- Presenting for elective tonsillectomy +/- adenoidectomy
- Provide informed consent / assent (as appropriate)
Exclusion Criteria
- History of liver or kidney disease
- Females with positive pregnancy test
- Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)
- Consistent daily opioid use for chronic pain ( >3 months)
Data sourced from ClinicalTrials.gov (NCT05244226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.