Dexmedetomidine in Pediatric Tonsillectomy

July 23, 2021 updated by: Olutoyin A. Olutoye, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital, Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of Post-Operative Rescue Morphine Required for Analgesia
Time Frame: From admission to discharge from PACU, up to 1 hour
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
Time Frame: 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.
From admission to discharge from PACU, up to 1 hour
Duration of Oxygen Supplementation
Time Frame: 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.
From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes
Time to PACU Discharge Readiness
Time Frame: 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
From admission to discharge from PACU, no time limit
Number of Participants With Emergence Agitation
Time Frame: 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.
From admission to discharge from PACU, no time limit
Number of Participants With Postoperative Complications
Time Frame: 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
From admission to discharge from PACU, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Olutoyin A Olutoye, M.D., Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 2010

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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