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

Sponsor
Indiana University (Other)
Overall Status
Terminated
CT.gov ID
NCT02436265
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
34
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Jun 23, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

ArmIntervention/Treatment
Sham Comparator: Group 1 Ropivacaine

Group 1 Ropivacaine Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine

Drug: Ropivacaine
Ropivacaine only
Other Names:
  • Ropi
  • Active Comparator: Group 2 Ropivacaine and Dexamethasone

    Group 2 Ropivacaine/dexamethasone Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine and 0.1mg/kg of intravenous dexamethasone immediately after caudal placement

    Drug: Dexamethasone
    IV dexamethasone
    Other Names:
  • IV Decadron
  • Drug: Ropivacaine
    Ropivacaine only
    Other Names:
  • Ropi
  • Outcome Measures

    Primary Outcome Measures

    1. Average Pain Scores Over 24 Hours [24 hours]

      Will track the trend of pain scores for both arms to note differences in pain score based on intervention received. Pain scores will be based on a patient verbal response of 0-10 pain, 0 being no pain and 10 being worst pain, or with a FLACC score (Face, Legs, Activity, Cry, Consolability scale) of 0-10 if patient unable to communicate verbally

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age 2 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Riley Hospital for ChildrenIndianapolisIndianaUnited States46202

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Aali M Shah, MD, Indiana University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Aali M. Shah, Aali Shah, MD, Indiana University
    ClinicalTrials.gov Identifier:
    NCT02436265
    Other Study ID Numbers:
    • 1408968524
    First Posted:
    May 6, 2015
    Last Update Posted:
    May 7, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Aali M. Shah, Aali Shah, MD, Indiana University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleGroup 1 RopivacaineGroup 2 Ropivacaine and Dexamethasone
    Arm/Group DescriptionGroup 1 Ropivacaine Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine Ropivacaine: Ropivacaine onlyGroup 2 Ropivacaine/dexamethasone Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine and 0.1mg/kg of intravenous dexamethasone immediately after caudal placement Dexamethasone: IV dexamethasone Ropivacaine: Ropivacaine only
    Period Title: Overall Study
    STARTED34
    COMPLETED34
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleRopivacaine Only GroupRopivaciane + IV DexamethasoneTotal
    Arm/Group DescriptionPatients receiving caudals with local anesthetic, but no IV dexamethasonePatients receiving caudals with local anesthetic +0/1mg/kg IV dexamethasoneTotal of all reporting groups
    Overall Participants347
    Age (Count of Participants)
    <=18 years
    3
    100%
    4
    100%
    7
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    1
    33.3%
    1
    25%
    2
    28.6%
    Male
    2
    66.7%
    3
    75%
    5
    71.4%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%

    Outcome Measures

    1. Primary Outcome
    TitleAverage Pain Scores Over 24 Hours
    DescriptionWill track the trend of pain scores for both arms to note differences in pain score based on intervention received. Pain scores will be based on a patient verbal response of 0-10 pain, 0 being no pain and 10 being worst pain, or with a FLACC score (Face, Legs, Activity, Cry, Consolability scale) of 0-10 if patient unable to communicate verbally
    Time Frame24 hours

    Outcome Measure Data

    Analysis Population Description
    The study was abandoned/terminated. Enrollment in the trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. No participants were analyzed.
    Arm/Group TitleRopivacaine OnlyRopivaciane + IV Dexamethasone
    Arm/Group Descriptioncaudal analgesia with 0.2% ropivacaine onlyCaudal analgesia with IV dexamethasone
    Measure Participants00

    Adverse Events

    Time Frame24 hours
    Adverse Event Reporting Description
    Arm/Group TitleRopivacaine OnlyRopivacaine + IV Dexamethasone
    Arm/Group DescriptionCaudal analgesia with 0.2% ropivacaine onlyCaudal analgesia with 0.2% ropivacaine only plus IV dexamethasone 0.1 mg/kg
    All Cause Mortality
    Ropivacaine OnlyRopivacaine + IV Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/3 (0%) 0/4 (0%)
    Serious Adverse Events
    Ropivacaine OnlyRopivacaine + IV Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/3 (0%) 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Ropivacaine OnlyRopivacaine + IV Dexamethasone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/3 (0%) 0/4 (0%)

    Limitations/Caveats

    The study was abandoned/terminated. Enrollment in the trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. No participants were analyzed.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleAali shah MD
    OrganizationIndiana University
    Phone317-944-9981
    Emailashah9@iuhealth.org
    Responsible Party:
    Aali M. Shah, Aali Shah, MD, Indiana University
    ClinicalTrials.gov Identifier:
    NCT02436265
    Other Study ID Numbers:
    • 1408968524
    First Posted:
    May 6, 2015
    Last Update Posted:
    May 7, 2021
    Last Verified:
    Apr 1, 2021