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Completed

NCT Number: NCT01057381

Dexmedetomidine in Pediatric Tonsillectomy

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.

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Key information

Conditions

Pediatric Adenotonsillectomy Post Operative Analgesia

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine 0.75 mcg/kg

Drug

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

Other names: Precedex

Morphine 50 mcg/kg

Drug

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

Other names: Morphine

Morphine 100 mcg/kg

Drug

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

Other names: Morphine

Dexmedetomidine 1 mcg/kg

Drug

Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia

Other names: Precedex

Primary outcomes

  1. Amount of Post-Operative Rescue Morphine Required for Analgesia

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2010
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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