High Volume Caudal Study

Effect of Clonidine on High Volume-Low Concentration Caudals

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.

Study Overview

• Status: Completed
• Conditions: Male Circumcision
• Intervention / Treatment: Drug: High Volume-Low Concentration without Clonidine; Drug: High Volume-Low Concentration with clonidine

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Christopher Heine, MD; Phone Number: (843) 792-5035; Email: heinec@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Volume-Low Concentration without Clonidine; 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; 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
Experimental: High Volume-Low Concentration with clonidine; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: Pro00091670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No