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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00678379 |
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsillar fossa prior to removal. While these studies have shown great promise, no large randomized trial of the most promising medications has been conducted. Because of this, many otolaryngologists do not administer intra-operative medications aimed at reducing post-operative pain. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: lidocaine + bupivacaine Drug: normal saline Drug: lidocaine + bupivacaine + clonidine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics |
Estimated Enrollment: | 120 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
Normal Saline
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Drug: normal saline
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline |
B: Active Comparator
Lidocaine (1%) + Bupivacaine 0.5%
|
Drug: lidocaine + bupivacaine
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%) |
C: Experimental
Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg
|
Drug: lidocaine + bupivacaine + clonidine
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg) |
Ages Eligible for Study: | 3 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jonathan R Moss, MD, MPH | 615-300-2290 | jonathan.moss@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University Monroe Carrel Jr. Children's Hospital | Recruiting |
Nashville, Tennessee, United States, 37299 |
Principal Investigator: | Jonathan R Moss, MD, MPH | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Jonathan R. Moss, MD MPH ) |
Study ID Numbers: | 080127 |
Study First Received: | May 8, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00678379 |
Health Authority: | United States: Food and Drug Administration |
Tonsillectomy Postoperative Pain Clonidine Anesthetics, Local |
Signs and Symptoms Postoperative Complications Clonidine Lidocaine |
Bupivacaine Pain Pain, Postoperative |
Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents Antihypertensive Agents Anesthetics, Local |
Pharmacologic Actions Adrenergic Agonists Pathologic Processes Autonomic Agents Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents |