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Ultra Low Dose Naloxone with Fentanyl in Pediatric ICU
NCT00286052Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2002
- Countries
- 1
- Sponsor
- UT Southwestern Medical Center
- Modality
- Orthosteric Ligands
- Drugs
- naloxone
- Conditions
- opioid toleranceopioid withdrawal
01
Overview
Phase 3, randomised, double-blind trial in opioid tolerance and opioid withdrawal comparing Low Dose Naloxone with Placebo (2 arms). Primary endpoint: Maximum Cumulative Daily Fentanyl Dose. Started Dec 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Low Dose Naloxone
Continuous infusion of Naloxone (0.25 mcg/kg/hr) + Fentanyl
Placebo
Continuous infusion of Normal Saline + Fentanyl
03
Endpoints
Primary
Maximum Cumulative Daily Fentanyl Dose
Secondary
Number of Rescue Fentanyl Boluses
Number of Rescue Midazolam Boluses
Total Midazolam Dose
Narcotic Withdrawal Scale Score
Modified Motor Activity Assessment Score
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