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

Cryptorchidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604915
• Other study ID #: 4-2012-0149
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: July 5, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptorchidism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Khafagy HF, Refaat AI, El-Sabae HH, Youssif MA. Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. J Anesth. 2010 Aug;24(4):531-6. doi: 10.1007/s00540-010-0949-7. Epub 2010 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No