High Volume Caudal Study

NCT04263064 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: Pro00091670
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Male Circumcision

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Hemodynamic Changes

  24 hours

• Incidence of Emergence Delirium

  24 hours

• Sedation Levels

  24 hours

• Average Time to Discharge

  24 hours

Study Arms (2)

High Volume-Low Concentration without Clonidine

ACTIVE COMPARATOR

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

High Volume-Low Concentration with clonidine

EXPERIMENTAL

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

Interventions

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 without Clonidine

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).

High Volume-Low Concentration with clonidine

Eligibility Criteria

• Age: 0 Years - 3 Years
• Gender Eligibility Details: presenting for penile circumcision
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to clonidine, epinephrine, or amide local anesthetics
• Inability or unwillingness of parent or legal guardian to give informed consent

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christopher Heine, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor and patient blinded to the medications in the block that the patient receives.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 10, 2020
• Study Start: March 6, 2020
• Primary Completion: August 17, 2022
• Study Completion: August 19, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)