NCT01057381

Dexmedetomidine in Pediatric Tonsillectomy

Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.

Detailed description

Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids. As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.

Conditions

• Pediatric Adenotonsillectomy
• Post Operative Analgesia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine 0.75 mcg/kg	Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
DRUG	Morphine 50 mcg/kg	Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
DRUG	Morphine 100 mcg/kg	Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
DRUG	Dexmedetomidine 1 mcg/kg	Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-01-27
• Last updated: 2021-07-27
• Results posted: 2021-02-01

Locations

1 site across 1 country: United States