Dexmedetomidine in Pediatric Tonsillectomy

Study Overview
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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.

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.

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

Conditions
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Pediatric Adenotonsillectomy, Post Operative Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine 0.75 mcg/kg
* Drug: Morphine 50 mcg/kg
* Drug: Morphine 100 mcg/kg
* Drug: Dexmedetomidine 1 mcg/kg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine 0.75 mcg/kg<br>Intraoperative administration for analgesia. | Drug: Dexmedetomidine 0.75 mcg/kg<br>* Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.<br>* Other names: Precedex;|
| Active Comparator: Dexmedetomidine 1mcg/kg<br>Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia | Drug: Dexmedetomidine 1 mcg/kg<br>* Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia<br>* Other names: Precedex;|
| Active Comparator: Morphine 50 mcg/kg<br>Intra-operative administration of morphine 50 mcg/kg for analgesia | Drug: Morphine 50 mcg/kg<br>* Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia<br>* Other names: Morphine;|
| Active Comparator: Morphine 100mcg/kg<br>Intra-operative administration of morphine 100mcg/kg for analgesia | Drug: Morphine 100 mcg/kg<br>* Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia<br>* Other names: Morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Post-Operative Rescue Morphine Required for Analgesia |  | From admission to discharge from PACU, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | From admission to discharge from PACU, no time limit | 
| Number of Participants With Postoperative Complications | Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU | From admission to discharge from PACU, up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Adenotonsillectomy, Postoperative analgesia