Dexmedetomidine in Pediatric Tonsillectomy

Phase 4

Completed

Conditions: Pediatric Adenotonsillectomy
Post Operative Analgesia

Interventions: Drug: Morphine 50 mcg/kg
Drug: Morphine 100 mcg/kg
Drug: Dexmedetomidine 0.75 mcg/kg
Drug: Dexmedetomidine 1 mcg/kg

Registration Number: NCT01057381

Lead Sponsor: Baylor College of Medicine

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine 50 mcg/kg	Morphine 50 mcg/kg	Intra-operative administration of morphine 50 mcg/kg for analgesia
Morphine 100mcg/kg	Morphine 100 mcg/kg	Intra-operative administration of morphine 100mcg/kg for analgesia
Dexmedetomidine 0.75 mcg/kg	Dexmedetomidine 0.75 mcg/kg	Intraoperative administration for analgesia.
Dexmedetomidine 1mcg/kg	Dexmedetomidine 1 mcg/kg	Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia

Primary Outcome Measures

Name	Time	Method
Amount of Post-Operative Rescue Morphine Required for Analgesia	From admission to discharge from PACU, up to 1 hour

Secondary Outcome Measures

Name	Time	Method
Morphine Rescue Doses Needed by Participants	From admission to discharge from PACU, up to 1 hour	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.
Duration of Oxygen Supplementation	From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes	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 to PACU Discharge Readiness	From admission to discharge from PACU, no time limit	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
Number of Participants With Emergence Agitation	From admission to discharge from PACU, no time limit	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.
Number of Participants With Postoperative Complications	From admission to discharge from PACU, up to 1 hour	Post-operative complications including emesis, prolonged oxygen requirement or post- tonsillectomy bleed assessed up to 1 hour in PACU