Early Phase 1
N=188
Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Obstructive Sleep Apnea · Tonsillitis
Bottom Line
View on ClinicalTrials.gov: NCT04230681 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Patients Requiring Rescue Intravenous Opioid — 48; 66 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Hydromorphone (Drug); Fentanyl (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Requiring Rescue Intravenous Opioid |
48; 66 | — |
| SECONDARY Evaluation of Participant's Pain |
2.8; 4.3; 2.7; 3.7; 2.3; 3.5 | — |
| SECONDARY Evaluation of Participant's SpO2 Saturation |
96.9; 96.6; 97.3; 96.1; 97.4; 97.3 | — |
| SECONDARY Respiratory and PONV Events in PACU |
3; 4; 9; 11; 1; 2 | — |
| SECONDARY Respiratory and PONV Events at Home |
10; 13; 7; 9; 1; 2 | — |
Summary
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04230681). 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.