High Volume Caudal Study

Study Overview
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Brief Summary
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The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.

Official Title
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Effect of Clonidine on High Volume-Low Concentration Caudals

Conditions
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Male Circumcision

Intervention / Treatment
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* Drug: High Volume-Low Concentration without Clonidine
* Drug: High Volume-Low Concentration with clonidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 years old or less Weight <= 13.3kg American Society of Anesthesiology Physical Status (ASA) 1 or 2 Undergoing circumcision surgery Patients whose plan of care includes caudal block Exclusion Criteria: Known allergy to clonidine, epinephrine, or amide local anesthetics Inability or unwillingness of parent or legal guardian to give informed consent

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Prospective, randomized, observer blinded study will attempt to determine if there is any benefit to the addition of clonidine to a HVLC caudal block, both in duration of analgesia and occurrence of emergence agitation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Volume-Low Concentration without Clonidine<br>The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine). | Drug: High Volume-Low Concentration without Clonidine<br>* The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block<br>|
| Experimental: High Volume-Low Concentration with clonidine<br>The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine). | Drug: High Volume-Low Concentration with clonidine<br>* The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Pain | The effect of clonidine on the duration of the analgesia provided by a high volume-low concentration caudal will be measured in the Post Anesthesia Care Unit pain assessments using CHEOPS score every at 0, 30, 60, and 90 minutes after arrival to PACU. The CHEOPS pain score tool is an observational scale for measuring postoperative pain in children aged 1-7 yrs. The tool includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain). | 24 hours | 
| Administration of Rescue Pain Medications | Data will be collected and analyzed on the need for rescue pain medications by collecting doses of opioids administered the Post Anesthesia Care Unit. | 24 hours | 
| Time to first Administration of Acetaminophen | 24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Changes | A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area | 24 hours | 
| Incidence of Emergence Delirium | The incidence of emergence delirium will be collected utilizing the PAED Scale at 0, 30, 60, and 90 minutes after arrival to the Post Anesthesia Care Unit. The PAED scale will measure the presence of delirium by scoring behaviors from 1-4 (1=calm, 2=not calm but consolable, 3=moderately agitate, restless or not easily calmed, 4=combative, excited, thrashing around) | 24 hours | 
| Sedation Levels | Measured in PACU utilizing Ramsay Sedation Scale at 0, 30, 60, and 90 minutes after arrival in PACU. The Ramsay sedation scale is a scoring of responses (1-6) [1=anxious or restless, 2=cooperative, oriented, tranquil, 3=responding to commands, 4=brisk response to stimulus, 5=sluggish response to stimulus, 6=no response to stimulus]. | 24 hours | 
| Average Time to Discharge | time of arrival to PACU and discharge time | 24 hours |