High Volume Caudal Study

Early Phase 1CompletedNCT04263064

Medical University of South Carolina129 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

129

Conditions

Male Circumcision

Interventions

High Volume-Low Concentration without ClonidineDRUG

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

High Volume-Low Concentration with clonidineDRUG

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).

Eligibility

Sex: MALEMin age: 0 YearsMax age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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

Time frame: 24 hours

Secondary Outcomes

Hemodynamic Changes

A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area

Time frame: 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)

Time frame: 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) \[1=anxious or restless, 2=cooperative, oriented, tranquil, 3=responding to commands, 4=brisk response to stimulus, 5=sluggish response to stimulus, 6=no response to stimulus\].

Data from ClinicalTrials.gov

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