drugset / Trial / NCT02512783
Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
Timeline
- Start
- 2013-05
- Primary completion
- 2014-06
- Completion
- 2014-06
Outcome
Outcome not reported
Stopped: “Interim analysis indicated treatment was effective and statistically significant”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lidocaine | Other / unclassified | 1 ml | — |
| Comparator | Propofol | Small molecule | — | Intravenous |
Indications
No indication recorded.