High Volume Caudal Study

Male Circumcision Clinical Trial

Official title:

Effect of Clonidine on High Volume-Low Concentration Caudals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263064
• Other study ID #: Pro00091670
• Status: Completed
• Phase: Early Phase 1
• Start date: March 6, 2020
• Est. completion date: August 19, 2022

Study information

• Verified date: March 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 19, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 0 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Male Circumcision

Intervention

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
• 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).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Hemodynamic Changes	A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area	24 hours
Secondary	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)	24 hours
Secondary	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].	24 hours
Secondary	Average Time to Discharge	time of arrival to PACU and discharge time	24 hours