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Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia on Hypospadias Surgery

NCT06747975 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-24

No results posted yet for this study

Summary

caudal epidural block is a technique used as an adjuvant to general anesthesia for postoperative analgesia in pediatric patients,especially those with infraumbilical, perineal and lower extremity surgery , because it reduces the need for perioperative and postoperative analgesia, reduces the need for general anesthesia, accelerates the awakening, suppresses the surgical neurohumoral stress response and can be performed easily The objective of the current study is to determine the efficacy and safety of prophylactic intravenous administration of combination of 0.1mg/kg of dexamethasone plus 4mg of ondansetron immediately before establishment of caudal block for prevention of Nausea\&vomiting and Shivering in pediatric patients undergoing infra umbilical surgeries

Conditions

  • Caudal Anesthesia

Interventions

DRUG

Dexamethasone and Ondansetron

patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline

DRUG

Bupivacaine + saline

patients will receive caudal epidural block (0.5 mL/kg of bupivacaine 0.25% only) and IV 5 mL normal saline

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2026-03-01
FDA Drug
Yes

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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 NCT06747975 on ClinicalTrials.gov