An Early Phase 1 interventional study of High Volume-Low Concentration without Clonidine and High Volume-Low Concentration with clonidine in Male Circumcision, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to male participants aged 0 Years to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Medical University of South Carolina · Early Phase 1, Interventional, and Treatment
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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Exclusion Criteria:
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
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
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
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).
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).
Time frame: 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.
Time frame: 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
Time frame: 24 hours
Hemodynamic Changes
A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area
Time frame: 24 hours
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)
Time frame: 24 hours
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) \[1=anxious or restless, 2=cooperative, oriented, tranquil, 3=responding to commands, 4=brisk response to stimulus, 5=sluggish response to stimulus, 6=no response to stimulus\].
Time frame: 24 hours
Average Time to Discharge
time of arrival to PACU and discharge time
Time frame: 24 hours
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina