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

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ClinicalTrials.gov Identifier: NCT01604915

Recruitment Status : Completed

First Posted : May 24, 2012

Last Update Posted : July 9, 2013

Sponsor:

Information provided by (Responsible Party):

Jeong-Rim LEE, Yonsei University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cryptorchidism	Procedure: Caudal block	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	May 2012
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate Ropivacaine monohydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Months to 5 Years (Child)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604915

Locations


Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Jeong-Rim LEE, Assistant Professor, Yonsei University
ClinicalTrials.gov Identifier:	NCT01604915 History of Changes
Other Study ID Numbers:	4-2012-0149
First Posted:	May 24, 2012 Key Record Dates
Last Update Posted:	July 9, 2013
Last Verified:	July 2013

Additional relevant MeSH terms:


Cryptorchidism Testicular Diseases Genital Diseases, Male Urogenital Abnormalities Congenital Abnormalities Gonadal Disorders Endocrine System Diseases Dexamethasone acetate Dexamethasone Ropivacaine BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents

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