MedTrace Logo

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

NCT02436265 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-05-07

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Surgery

Interventions

DRUG

Dexamethasone

IV dexamethasone

DRUG

Ropivacaine

Ropivacaine only

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Aali M Shah, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-06-23
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436265 on ClinicalTrials.gov