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Sponsored by: |
University of Medicine and Dentistry New Jersey |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00468052 |
Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.
Condition | Intervention | Phase |
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Obstructive Sleep Apnea |
Drug: dexmedetomidine Drug: fentanyl |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Use of Dexmedetomidine Infusion for Analgesia and Emergence Agitation for Children Undergoing Tonsillectomy and Adenotonsillectomy |
Enrollment: | 121 |
Study Start Date: | March 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
UMDNJ University Hospital | |
Newark, New Jersey, United States, 07103 |
Principal Investigator: | Anuradha Patel, MD | University of Medicne & Dentistry of New Jersey |
Responsible Party: | UMDNJ ( Anuradha Patel, MD ) |
Study ID Numbers: | 0120060313 |
Study First Received: | April 27, 2007 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00468052 History of Changes |
Health Authority: | United States: Food and Drug Administration |
obstructive sleep apnea tonsillectomy adenoidectomy |
Neurotransmitter Agents Sleep Apnea Syndromes Fentanyl Adrenergic alpha-Agonists Adrenergic Agents Apnea Sleep Apnea, Obstructive Respiration Disorders Central Nervous System Depressants Sleep Disorders Dyssomnias |
Psychomotor Agitation Pain Adrenergic Agonists Sleep Disorders, Intrinsic Respiratory Tract Diseases Analgesics, Non-Narcotic Hypnotics and Sedatives Peripheral Nervous System Agents Analgesics Dexmedetomidine |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Sleep Apnea, Obstructive Sleep Disorders Adrenergic Agonists Sleep Disorders, Intrinsic Respiratory Tract Diseases Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine |
Analgesics Sleep Apnea Syndromes Adrenergic alpha-Agonists Apnea Nervous System Diseases Respiration Disorders Central Nervous System Depressants Dyssomnias Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Central Nervous System Agents |