Conditions: Postoperative Pain
Keywords: Tonsillectomy Postoperative Pain Clonidine Anesthetics, Local
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: no

Brief 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).

Detailed description:
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).

Arms:
arm 1: 1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy arm 2: Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy arm 3: Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy

Interventions: intervention 1: lidocaine (1%) + bupivacaine (0.5%) intervention 2: Normal saline intervention 3: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Intervention descriptions: intervention 1: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

B - lidocaine (1%) + bupivacaine (0.5%) intervention 2: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

A - normal saline intervention 3: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

Protocol document: