Dexmedetomidine in Pediatric Tonsillectomy

Baylor College of Medicine109 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

109

Conditions

Pediatric Adenotonsillectomy Post Operative Analgesia

Interventions

Dexmedetomidine 0.75 mcg/kgDRUG

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

Morphine 50 mcg/kgDRUG

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

Morphine 100 mcg/kgDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

Amount of Post-Operative Rescue Morphine Required for Analgesia

Time frame: From admission to discharge from PACU, up to 1 hour

Secondary Outcomes

Morphine Rescue Doses Needed by Participants

Subjects with a Children's Hospital of Eastern Ontario Pain Scale score greater than 8 received rescue morphine doses of 25 ug/kg IV at 10-minute intervals until the score was less than 8. Minimum and Maximum values: minimum score: 4 \& maximum score: 13. The higher the score ( \> 8), the greater the pain appreciated by the patient.

Time frame: From admission to discharge from PACU, up to 1 hour

Duration of Oxygen Supplementation

The subjects were then transported to the PACU with supplemental oxygen. Oxygen administration was continued after extubation until the patient was awake and could sustain room air saturations greater than 95% for 5 minutes. Duration of oxygen requirement was recorded as the time from tracheal extubation to cessation of oxygen supplementation in the PACU.

Time frame: From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes

Time to PACU Discharge Readiness

Patients were considered ready for discharge from the PACU when they attained an Aldrete score of 9 or more and were free from pain, nausea, and vomiting. Aldrete score ranges form 0 to 10 and patients greater than 8 are deemed satisfactory for discharge from the PACU

Time frame: From admission to discharge from PACU, no time limit

Number of Participants With Emergence Agitation

Patients in the PACU who were crying, restless, disoriented, unresponsive to the parent's voice, with non-purposeful thrashing movements requiring additional personnel to prevent bodily harm, and inconsolable even after parental presence, rescue analgesia and additional measures of comfort were considered to have emergence agitation.

Data from ClinicalTrials.gov

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