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

NCT01604915 | Completed DMC

• 1 other identifier: 4-2012-0149
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cryptorchidism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group R

PLACEBO COMPARATOR

Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered.

Procedure: Caudal block

Group DR

EXPERIMENTAL

Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR.

Procedure: Caudal block

Interventions

Caudal block PROCEDURE

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.

Group R

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA status I-II
• Children aged 6 months to 5 years
• Undergoing day-case unilateral orchiopexy

You may not qualify if:

• Hypersensitivity to any local anesthetics
• Bleeding diathesis
• Infections at puncture sites
• Preexisting neurological disease
• Diabetes mellitus

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

• 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.

  PMID: 20467878 BACKGROUND

• Kim EM, Lee JR, Koo BN, Im YJ, Oh HJ, Lee JH. Analgesic efficacy of caudal dexamethasone combined with ropivacaine in children undergoing orchiopexy. Br J Anaesth. 2014 May;112(5):885-91. doi: 10.1093/bja/aet484. Epub 2014 Feb 2.

  PMID: 24491414 DERIVED

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 24, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

KR (1)