Male Circumcision
Conditions
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.
Interventions
DRUGHigh 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
DRUGHigh 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
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessor and patient blinded to the medications in the block that the patient receives.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
0 Years to 3 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Pain | 24 hours | 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). |
| Administration of Rescue Pain Medications | 24 hours | 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 to first Administration of Acetaminophen | 24 hours | 24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Changes | 24 hours | A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area |
| Average Time to Discharge | 24 hours | time of arrival to PACU and discharge time |
| Incidence of Emergence Delirium | 24 hours | 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) |
| Sedation Levels | 24 hours | 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) \[1=anxious or restless, 2=cooperative, oriented, tranquil, 3=responding to commands, 4=brisk response to stimulus, 5=sluggish response to stimulus, 6=no response to stimulus\]. |
Countries
United States
Outcome results
None listed