Pediatric Tonsillectomy Pain Reduction Study

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Anesthetics; Bupivacaine; Clonidine; Lidocaine

Criteria

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