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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
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)
Vanderbilt University Monroe Carrel Jr. Children's Hospital
Nashville, Tennessee, United States
Total Number of Post-operative Doses of Analgesics.
The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)
Time frame: Post-operative thru day 7
Median Number of Pain Medication Doses
The median number of intravenous fentanyl doses administered in the PACU due to pain
Time frame: in recovery room
Total Time Until Discharge From Hospital.
Time frame: Day of Surgery
Mean Visual Analog Scale Pain Number.
Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever
Time frame: in recovery room; post-operative days 1,3,5 & 7
Number and Percent of Participants Able to Tolerate Only Liquids
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.
Number and Percent of Participants Able to Tolerate Only a Soft Diet
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.
Number and Percent of Participants Able to Tolerate a Regular Diet
The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 \& 7
Time frame: post-operative days 1,3,5 & 7.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.