Vanderbilt University Monroe Carrel Jr. Children's Hospital
Nashville, Tennessee, 37299, United States
NCT Number: NCT00678379
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).
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Notify Me3 year–17 year
All sexes
Interventional
Phase 3
Nashville, Tennessee, 37299, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Post-operative thru day 7
The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)
Time frame: in recovery room
The median number of intravenous fentanyl doses administered in the PACU due to pain
Time frame: Day of Surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Vanderbilt University Medical Center
Other
Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics
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