Comparison of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia in Children Undergoing Orchiopexy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cryptorchidism |
Procedure: Caudal block |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy |
- Time to first analgesic rescue medication [ Time Frame: from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation ] [ Designated as safety issue: No ]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.
| Enrollment: | 80 |
| Study Start Date: | May 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group R
Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered.
|
Procedure: Caudal block
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.
|
|
Experimental: Group DR
Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR.
|
Procedure: Caudal block
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.
|
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01604915
| Korea, Republic of | |
| Severance hospital | |
| Seoul, Korea, Republic of, 120-752 | |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeong-Rim LEE, Assistant Professor, Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01604915 History of Changes |
| Other Study ID Numbers: | 4-2012-0149 |
| Study First Received: | May 18, 2012 |
| Last Updated: | July 5, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Cryptorchidism Congenital Abnormalities Endocrine System Diseases Genital Diseases, Male Gonadal Disorders Testicular Diseases Urogenital Abnormalities BB 1101 Dexamethasone Dexamethasone 21-phosphate Dexamethasone acetate Ropivacaine Anesthetics Anesthetics, Local Anti-Inflammatory Agents |
Antiemetics Antineoplastic Agents Antineoplastic Agents, Hormonal Autonomic Agents Central Nervous System Agents Central Nervous System Depressants Enzyme Inhibitors Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 26, 2015