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

NCT02436265 | Terminated Phase 4 Results

• 1 other identifier: 1408968524
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Neuraxial; Caudal; Block; Anesthesia; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Average Pain Scores Over 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

  24 hours

Study Arms (2)

Group 1 Ropivacaine

SHAM COMPARATOR

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

Drug: Ropivacaine

Group 2 Ropivacaine and Dexamethasone

ACTIVE COMPARATOR

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; Drug: Ropivacaine

Interventions

Dexamethasone DRUG

IV dexamethasone

Also known as: IV Decadron

Group 2 Ropivacaine and Dexamethasone

Ropivacaine DRUG

Ropivacaine only

Also known as: Ropi

Group 1 Ropivacaine; Group 2 Ropivacaine and Dexamethasone

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Abnormal/difficult anatomy
• known allergy to ropivacaine or dexamethasone
• history of documented chronic pain
• existing infection at site of intended injection

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• 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.

  PMID: 23587875 BACKGROUND

• 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.

  PMID: 20659915 BACKGROUND

• 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.

  PMID: 21799397 BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Interventions

Dexamethasone; Calcium Dobesilate; Ropivacaine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines

Limitations and 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.

Results Point of Contact

• Title: Aali shah MD
• Organization: Indiana University

ashah9@iuhealth.org

317-944-9981

Study Officials

• Aali M Shah, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aali Shah, MD

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: May 6, 2015
• Study Start: February 1, 2015
• Primary Completion: June 23, 2017
• Study Completion: December 1, 2017
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-04

Locations

US (1)