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High Volume Caudal Study

NCT04263064 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-03-14

No results posted yet for this study

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

Interventions

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

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).

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Christopher Heine, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
3 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2022-08-17
Completion
2022-08-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04263064 on ClinicalTrials.gov