WithdrawnEarly Phase 1

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

Stopped: Never IRB reviewed or approved.

United States0Started 2017-01-01

Plain-language summary

The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

Who can participate

Age range2 Years – 18 Years

SexALL

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

Exclusion criteria

✕. Under age 2 years old or patients \> 18 years old
✕. Multiple Fractures
✕. Significant multisystem trauma
✕. Glasgow Coma Scale (GCS \< 15)
✕. Complex fractures that aren't deemed reducible in ED
✕. Reported Allergy to Alpha -2-agonists
✕. Pregnancy
✕. Intoxication

What they're measuring

Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine

Timeframe: 12 months

Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine

Timeframe: 12 months

Trial details

NCT IDNCT03466242

SponsorPhoenix Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-01

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