Phase 4
N=171
Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01244126 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score. — 2.9; 2.7; 2.0 units on a scale — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intranasal fentanyl (Drug); morphine IM (Drug); IV morphine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score. |
2.9; 2.7; 2.0 | 0.21 |
| SECONDARY Maximum PAED Score |
6.1; 6.3; 4.6 | 0.34 |
Summary
The purpose of this study is to compare the difference in effect of three clinically common methods of providing pain medication during surgery for ventilating tubes placed for recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a muscle, and morphine injected in a vein.
Eligibility Criteria
Inclusion Criteria
- bilateral myringotomy
Exclusion Criteria
- ASA greater than 2
- history of bleeding disorder/thrombocytopenia
- history of allergy to morphine or fentanyl
Data sourced from ClinicalTrials.gov (NCT01244126). 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.