WithdrawnPhase 4

Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department

Stopped: Sponsor left the hospital

0Started 2023-08

Plain-language summary

This study aims to compare efficacy of Procedural Sedation with Dexmedetomidine as compared to Midazolam in the pediatric Emergency Department. 210 children aged 6 months to 6 years will be included and randomly assigned to receiving oral or rectal midazolam (standard of care) or intranasal dexmedetomidine for procedures at the emergency department where mainly a sedation and no analgesia is sought. The procedure will be videotaped and analysis is blinded to the medication.

Who can participate

Age range6 Months – 6 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 aged between 6 months and 6 years presenting at the pediatric emergency department * Indication for midazolam as sedation * Signed informed consent Exclusion Criteria: * Contraindication for midazolam * Contraindication for dexmedetomidine * Contraindication for moderate sedation in general

What they're measuring

Efficacy of procedural sedation, using the 6 point Procedural Sedation State Scale PSSS

Timeframe: Initiation of procedure, around 30 minutes after medication was given

Trial details

NCT IDNCT03399838

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Procedural Anxiety trials