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Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgery

Intervention: Dexamethasone (Drug); Ropivacaine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
Aali M Shah, MD, Principal Investigator, Affiliation: Indiana University

Overall contact:
Aali M Shah, MD, Phone: 317-944-9981, Email: shaham@iupui.edu


Caudal injection of local anesthetic is a neuraxial technique routinely performed on young children for postoperative analgesia after lower abdominal and lower extremity surgical procedures. One of the major limitations of the use of single shot neuraxial injections for this purpose is the limited duration of action of the injected local anesthetic. Adjuvant medications, such as clonidine and epinephrine, have been added to the local anesthetic to prolong the duration of the neuraxial block, with varying results. Dexamethasone is a synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude of indications, including the prolongation of local anesthetic based analgesia. It has been shown that the administration of dexamethasone either intravenously or via perineural injection can significantly increase the duration of analgesia derived from a local anesthesia based peripheral nerve block. Literature also suggests that the effect of dexamethasone is equivalent whether given intravenously or perineurally. Interest in dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using a higher dose of dexamethasone (0. 5 mg/kg) than is routinely used in the pediatric population outside of airway procedures, which may expose patients to dose related side effects of dexamethasone. A large meta-analysis has suggested that 0. 1 mg/kg is effective for analgesic prolongation, but no direct study of low dose intravenous dexamethasone in combination with caudal anesthesia has been performed.

Clinical Details

Official title: Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery

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

Primary outcome: post operative anesthesia level

Detailed description: As dexamethasone is an inexpensive and commonly used medication, it would be beneficial to know if a similar prolongation of analgesia occurs when a local anesthetic is given neuraxially in combination with low dose intravenous dexamethasone. This project will investigate the efficacy of low dose intravenous (IV) dexamethasone in prolonging the duration of post operative analgesia provided by an intraoperative caudal injection of local anesthetic. All patients will be enrolled in the study the day of surgery, in the preoperative waiting area. The study will be explained by an anesthesiologist with extensive knowledge of the protocol. Computer randomization will occur for each patient. Randomization will not increase the risk to either group as all medications and techniques utilized for this study are commonly accepted for routine care for these patients.


Minimum age: 3 Months. Maximum age: 10 Years. Gender(s): Both.


Inclusion Criteria:

- age 3 months to 10 years

- Scheduled for elective inpatient genitourinary surgical procedure

- Caudal anesthesia standard of care for surgical procedure

- have provided parental consent and assent in accordance with the institutional review

board requirements Exclusion Criteria:

- Abnormal/difficult anatomy

- known allergy to ropivacaine or dexamethasone

- history of documented chronic pain

- existing infection at site of intended injection

Locations and Contacts

Aali M Shah, MD, Phone: 317-944-9981, Email: shaham@iupui.edu

Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Aali Shah, MD, Phone: 317-944-9981, Email: shaham@iupui.edu
Aali Shah, MD, Principal Investigator
Nicole Horn, MD, Sub-Investigator
Kristen Spisak, MD, Sub-Investigator
Brian Egan, MD, Sub-Investigator
Brandon Kibby, MD, Sub-Investigator
Morton Green, MD, Sub-Investigator
Additional Information

Related publications:

Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.

Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20.

De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2. Review.

Starting date: February 2015
Last updated: May 5, 2015

Page last updated: August 23, 2015

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