CompletedPhase 3

Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture

France60 participantsStarted 2007-01

Plain-language summary

It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

Who can participate

Age range5 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children between 5 and 16 years old * children with a disjoined bone fracture * children needed oral morphine analgesia * written informed consent from one or the two parents or legal pad Exclusion Criteria: * ASA score \> 2 * concomitant administration of oral analgesia (level II WHO classification) less than 6 hours * concomitant administration of benzodiazepine less than 24 hours

What they're measuring

Difference in the measurement of pain analogical scale values at 30 minutes between the two groups

Timeframe: after administration until 120 minutes

Trial details

NCT IDNCT00416039

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-11

View on ClinicalTrials.gov More Fractures trials