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Completed

NCT Number: NCT04263064

High Volume Caudal Study

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.

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Key information

Conditions

Male Circumcision

Age range

0 year–3 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Volume-Low Concentration without Clonidine

Drug

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 clonidine

Drug

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).

Primary outcomes

  1. Presence of Pain

    Time frame: 24 hours

    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).

  2. Administration of Rescue Pain Medications

    Time frame: 24 hours

    Data will be collected and analyzed on the need for rescue pain medications by collecting doses of opioids administered the Post Anesthesia Care Unit.

  3. Time to first Administration of Acetaminophen

    Time frame: 24 hours

    24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen

Secondary outcomes

  1. Hemodynamic Changes

    Time frame: 24 hours

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

  2. Incidence of Emergence Delirium

    Time frame: 24 hours

    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)

  3. Sedation Levels

    Time frame: 24 hours

    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].

  4. Average Time to Discharge

    Time frame: 24 hours

    time of arrival to PACU and discharge time

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Effect of Clonidine on High Volume-Low Concentration Caudals

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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