Comparison of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia in Children Undergoing Orchiopexy

Study Overview
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Brief Summary
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Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures. However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves. In order to decrease postoperative analgesic requirements after caudal block, various drugs such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been investigated. However, their use has been limited by adverse effects in children. Recently, many study suggested that epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults. But there is no study concerning the use of dexamethasone, as an adjuvant agent for the caudal epidural block in children. The investigators performed prospective randomized double-blind study to examine the analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing orchiopexy. 80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours. After discharge, rescue analgesic consumption, pain scores, and adverse effects were evaluated for 24h. The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.

Official Title
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Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy

Conditions
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Cryptorchidism

Intervention / Treatment
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* Procedure: Caudal block
* Procedure: Caudal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA status I-II Children aged 6 months to 5 years Undergoing day-case unilateral orchiopexy Exclusion Criteria: Hypersensitivity to any local anesthetics Bleeding diathesis Infections at puncture sites Preexisting neurological disease Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group R<br>Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered. | Procedure: Caudal block<br>* After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R.<br>|
| Experimental: Group DR<br>Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. | Procedure: Caudal block<br>* After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic rescue medication | The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview. | from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation |