Dexmedetomidine in Pediatric Tonsillectomy

Baylor College of Medicine

Status and phase: Completed; Phase 4

Conditions: Pediatric Adenotonsillectomy; Post Operative Analgesia

Treatments: Drug: Dexmedetomidine 1 mcg/kg; Drug: Dexmedetomidine 0.75 mcg/kg; Drug: Morphine 50 mcg/kg; Drug: Morphine 100 mcg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT01057381

H-17558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion criteria

• Children less than 3 years
• Children with uncorrected cardiac lesions
• Children with heart block or liver impairment
• Children with American Society of Anesthesiology Class 3 or 4.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 4 patient groups

Dexmedetomidine 0.75 mcg/kg

Active Comparator group

Description:

Intraoperative administration for analgesia.

Treatment:

Drug: Dexmedetomidine 0.75 mcg/kg

Dexmedetomidine 1mcg/kg

Active Comparator group

Description:

Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia

Treatment:

Drug: Dexmedetomidine 1 mcg/kg

Morphine 50 mcg/kg

Active Comparator group

Description:

Intra-operative administration of morphine 50 mcg/kg for analgesia

Treatment:

Drug: Morphine 50 mcg/kg

Morphine 100mcg/kg

Active Comparator group

Description:

Intra-operative administration of morphine 100mcg/kg for analgesia

Treatment:

Drug: Morphine 100 mcg/kg