Pediatric Tonsillectomy Pain Reduction Study

Completed · Phase 3

Conditions studied: Postoperative Pain

In brief

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).

Key facts

Study ID

NCT00678379

Run by

Vanderbilt University Medical Center

People needed

120

Starts

2008-04-01

Expected to finish

2009-11-01

Last updated by the study team

2017-07-02

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Diagnosis of obstructive sleep apnea
• Patient with peritonsillar abscess
• Allergy to study medication
• Any major systemic illness, genetic disorder or diagnosed syndrome
• Bleeding disorder

Where it is running

• Vanderbilt University Monroe Carrel Jr. Children's Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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