drugset / Trial / NCT03725995

Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

NCT03725995 ↗

Phase 2/3 Completed 63 enrolled Latakia University
RandomizedParallel-groupDouble-blindTreatment

Summary

Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration. Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.

Timeline

Start
2017-06-01
Primary completion
2018-01-01
Completion
2018-10-10

Outcome

Met primary endpoint

paper less discomfort with IN midazolam administration (median WBS = 3, interquartile range [IQR] = 0-6) than those who received placebo PMID 27739142 ↗

paper than those who received placebo (median WBS = 8, IQR = 2-9; p = 0.006). PMID 27739142 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 2 % Intranasal
Background Midazolam Small molecule 0.5 mg/kg Intranasal

Indications

No indication recorded.