Dexmedetomidine in Pediatric Tonsillectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pediatric Adenotonsillectomy Post Operative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine 0.75 mcg/kg

Intraoperative administration for analgesia.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 0.75 mcg/kg

Intervention Type DRUG

Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.

Dexmedetomidine 1mcg/kg

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 1 mcg/kg

Intervention Type DRUG

Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia

Morphine 50 mcg/kg

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

Group Type ACTIVE_COMPARATOR

Morphine 50 mcg/kg

Intervention Type DRUG

Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia

Morphine 100mcg/kg

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

Group Type ACTIVE_COMPARATOR

Morphine 100 mcg/kg

Intervention Type DRUG

Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia

Interventions

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Dexmedetomidine 0.75 mcg/kg

Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.

Intervention Type DRUG

Morphine 50 mcg/kg

Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia

Intervention Type DRUG

Morphine 100 mcg/kg

Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia

Intervention Type DRUG

Dexmedetomidine 1 mcg/kg

Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia

Intervention Type DRUG

Other Intervention Names

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Precedex Morphine Morphine Precedex

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes