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

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Dexmedetomidine; Midazolam

Criteria

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