Pediatric Tonsillectomy Pain Reduction Study

Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics

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).

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).

Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy

Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%)

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline

Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)

The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7

The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7

The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7

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

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