Pediatric Tonsillectomy Pain Reduction Study
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics |
- Total number of post-operative doses of analgesics. [ Time Frame: Post-operative days 1,3,5 & 7 ] [ Designated as safety issue: No ]
- Mean number of pain medication doses per day. [ Time Frame: in recovery room; post-operative days 1,3,5 & 7 ] [ Designated as safety issue: No ]
- Total time until discharge from hospital. [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
- Mean visual analog scale pain number. [ Time Frame: in recovery room; post-operative days 1,3,5 & 7 ] [ Designated as safety issue: No ]
- Type of diet patient is able to tolerate. [ Time Frame: post-opeartive days 1,3,5 & 7. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
Normal Saline
|
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 |
|
Active Comparator: B
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%) Other Name: Duraclon
|
|
Experimental: C
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) |
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 3 - 17 years old
- BMI < 35
- Negative pregnancy test in female patients age 10 and older
- Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy
Exclusion Criteria:
- Diagnosis of obstructive sleep apnea
- Patient with peritonsillar abscess
- Allergy to study medication
- Any major systemic illness, genetic disorder or diagnosed syndrome
- Bleeding disorder
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Monroe Carrel Jr. Children's Hospital | |
| Nashville, Tennessee, United States, 37299 | |
| Principal Investigator: | Jonathan R Moss, MD, MPH | Vanderbilt University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jonathan R. Moss, MD MPH, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00678379 History of Changes |
| Other Study ID Numbers: | 080127 |
| Study First Received: | May 8, 2008 |
| Last Updated: | December 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
Tonsillectomy Postoperative Pain Clonidine Anesthetics, Local |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Anesthetics, Local Bupivacaine Lidocaine Anesthetics Clonidine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on May 23, 2013