NCT04263064

High Volume Caudal Study

Effect of Clonidine on High Volume-Low Concentration Caudals

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 0 Years – 3 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2020-03-06
• Primary completion: 2022-08-17
• Completion: 2022-08-19
• First posted: 2020-02-10
• Last updated: 2023-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study