Pediatric Tonsillectomy Pain Reduction Study

Phase 3

Completed

Interventions: Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Drug: lidocaine (1%) + bupivacaine (0.5%)
Drug: Normal saline

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lidocaine + Bupivacaine + Clondine	Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)	Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy
Lidocaine (1%) + Bupivacaine 0.5%	lidocaine (1%) + bupivacaine (0.5%)	Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy
Normal Saline	Normal saline	1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy

Primary Outcome Measures

Name	Time	Method
Total Number of Post-operative Doses of Analgesics.	Post-operative thru day 7	The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)

Secondary Outcome Measures

Name	Time	Method
Median Number of Pain Medication Doses	in recovery room	The median number of intravenous fentanyl doses administered in the PACU due to pain
Total Time Until Discharge From Hospital.	Day of Surgery
Mean Visual Analog Scale Pain Number.	in recovery room; post-operative days 1,3,5 & 7	Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever
Number and Percent of Participants Able to Tolerate Only Liquids	post-operative days 1,3,5 & 7.	The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 \& 7
Number and Percent of Participants Able to Tolerate Only a Soft Diet	post-operative 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
Number and Percent of Participants Able to Tolerate a Regular Diet	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