Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair

NCT03902249 | Completed Phase 4

• 1 other identifier: DexaProtocol
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.

Conditions

Postoperative Pain; Hypospadias

Keywords

Intravenous Dexamethasone; Pudendal nerve block; Analgesia; Postoperative pain; Children; Hypospadias

Outcome Measures

Primary Outcomes (2)

• The mean time to first rescue analgesic

  Time from the end of surgery to the first administration of rescue analgesic

  The first 24 hours after surgery

• number of rescue analgesic consumption

  Total number of rescue analgesic consumption for each patient

  The first 24 hours after surgery

Secondary Outcomes (2)

• pain scores (CHEOPS)

  Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24

• Number of episodes of postoperative nausea and vomiting

  The first 24 hours after surgery

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline

Drug: Dexamethasone

Placebo group

PLACEBO COMPARATOR

Patients who received the same volume of saline as the study group (8ml)

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone group; Placebo group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA physical status classification 1 or 2
• Procedure: hypospadias repair
• Eligible for a pudendal nerve block

You may not qualify if:

• parents or patient refusal
• nerve block failure
• Peroperative complication.

Sponsors & Collaborators

• Dr Sonia ben khalifa (PhD): lead

Related Publications (1)

• Khalifa SB, Slimene AB, Blaiti H, Kaddour R, Hassen AF, Pardessus P, Brasher C, Dahmani S. The potentiating effect of intravenous dexamethasone upon preemptive pudendal block analgesia for hypospadias surgery in children managed with Snodgrass technique: a randomized controlled study : Dexamethasone for pain management in children. BMC Anesthesiol. 2024 Apr 16;24(1):145. doi: 10.1186/s12871-024-02536-3.

  PMID: 38627668 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Hypospadias; Agnosia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04