Pediatric Tonsillectomy Pain Reduction Study

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: lidocaine (1%) + bupivacaine (0.5%)
* Drug: Normal saline
* Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy | Drug: Normal saline<br>* Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline<br>|
| Active Comparator: Lidocaine (1%) + Bupivacaine 0.5%<br>Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy | Drug: lidocaine (1%) + bupivacaine (0.5%)<br>* Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%)<br>|
| Experimental: Lidocaine + Bupivacaine + Clondine<br>Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy | Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)<br>* Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Post-operative thru day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Number of Pain Medication Doses | The median number of intravenous fentanyl doses administered in the PACU due to pain | in recovery room | 
| Total Time Until Discharge From Hospital. |  | 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 | 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 | 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 | 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 | post-operative days 1,3,5 & 7. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clonidine, Tonsillectomy, Postoperative Pain, Anesthetics, Local