An interventional study of Caudal block and Caudal block in Cryptorchidism, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to male participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2013-07-09.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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.
40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 26 interventional studies indexed under Cryptorchidism.
Browse Cryptorchidism studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered.
Procedure: Caudal block
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. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R.
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.
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.
Time frame: from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation
The record gives a start of May 2012, a primary completion of Nov 2012 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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