Phase 4
Completed N=171
Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy
Source: ClinicalTrials.gov NCT01244126 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score. — 2.9; 2.7; 2.0 units on a scale — p=0.21
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.
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 |
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. Informational only — not medical advice.