Phase 4
N=109
Dexmedetomidine in Pediatric Tonsillectomy
Pediatric Adenotonsillectomy · Post Operative Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT01057381 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Amount of Post-Operative Rescue Morphine Required for Analgesia — 45.2; 37.0; 43.3; 36.5 ug/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine 0.75 mcg/kg (Drug); Morphine 50 mcg/kg (Drug); Morphine 100 mcg/kg (Drug); Dexmedetomidine 1 mcg/kg (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Post-Operative Rescue Morphine Required for Analgesia |
45.2; 37.0; 43.3; 36.5 | — |
| SECONDARY Morphine Rescue Doses Needed by Participants |
6; 3; 1; 4; 2; 14 | — |
| SECONDARY Duration of Oxygen Supplementation |
17; 19; 20; 18 | — |
| SECONDARY Time to PACU Discharge Readiness |
115; 116; 117; 122 | — |
| SECONDARY Number of Participants With Emergence Agitation |
5; 4; 4; 1 | — |
| SECONDARY Number of Participants With Postoperative Complications |
2; 0; 0; 3; 0; 0 | — |
Summary
The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.
Eligibility Criteria
Inclusion Criteria
- Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.
Exclusion Criteria
- Children less than 3 years
- Children with uncorrected cardiac lesions
- Children with heart block or liver impairment
- Children with American Society of Anesthesiology Class 3 or 4.
Data sourced from ClinicalTrials.gov (NCT01057381). 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.