Dexmedetomidine in Pediatric Tonsillectomy

Post Operative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057381
• Other study ID #: H-17558
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Est. completion date: December 2010

Study information

• Verified date: July 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Adenotonsillectomy
• Post Operative Analgesia

Intervention

Drug:
• Dexmedetomidine 0.75 mcg/kg
Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
• Morphine 50 mcg/kg
Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
• Morphine 100 mcg/kg
Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
• Dexmedetomidine 1 mcg/kg
Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia

Locations

Country	Name	City	State
United States	Texas Children's Hospital, Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Post-Operative Rescue Morphine Required for Analgesia		From admission to discharge from PACU, up to 1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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