Dexmedetomidine in Pediatric Tonsillectomy
This study has been completed.
Sponsor:
Baylor College of Medicine
Information provided by (Responsible Party):
OLUTOYIN A. OLUTOYE, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01057381
First received: January 25, 2010
Last updated: August 9, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatric Adenotonsillectomy Post Operative Analgesia |
Drug: Dexmedetomidine 0.75 mcg/kg Drug: Morphine 50 mcg/kg Drug: Morphine 100 mcg/kg Drug: Dexmedetomidine 1 mcg/kg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient |
Resource links provided by NLM:
Further study details as provided by Baylor College of Medicine:
Primary Outcome Measures:
- opioid sparing effect of dexmedetomidine following adenotonsillectomy [ Time Frame: First hour following adenotonsillectomy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Degree of sedation [ Time Frame: Over the first hour following surgery ] [ Designated as safety issue: Yes ]
| Enrollment: | 109 |
| Study Start Date: | August 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 Name: 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 Name: Morphine
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057381
Locations
| United States, Texas | |
| Texas Children's Hospital, Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Baylor College of Medicine
Investigators
| Principal Investigator: | Olutoyin A Olutoye, M.D. | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | OLUTOYIN A. OLUTOYE, Associate Professor of Anesthesiology & Pediatrics, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01057381 History of Changes |
| Other Study ID Numbers: | H-17558 |
| Study First Received: | January 25, 2010 |
| Last Updated: | August 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Baylor College of Medicine:
|
Adenotonsillectomy Postoperative analgesia Pediatrics |
Additional relevant MeSH terms:
|
Morphine Dexmedetomidine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Central Nervous System Depressants Narcotics Hypnotics and Sedatives Analgesics, Non-Narcotic Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013