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

NCT06747975 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: dexamethasone+ondansetron PONV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

dexamethasone; ondansetron

Outcome Measures

Primary Outcomes (1)

• the incidence of all emesis

  the incidence of all emesis in the 24 h after surgery (PONV).

  24 hours

Study Arms (2)

group A

EXPERIMENTAL

fifty 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: Dexamethasone and Ondansetron; Drug: Bupivacaine + saline

group B

PLACEBO COMPARATOR

fifty 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

Interventions

Dexamethasone and Ondansetron DRUG

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

group A

Bupivacaine + saline DRUG

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

group A; group B

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 2 to 12 years old.
• Patients with stable vital signs.
• Patients with normal laboratory investigations.
• Patients undergoing Caudal anaesthesia for infraumbilical surgeries

You may not qualify if:

• Patient's parental refusal.
• Age \< 2 or \> 12 years.
• Contraindications to Caudal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection ,pilonidal cyst and congenital anomalies of lower spine because of unclear or impalpable anatomy
• Patients with cardiac morbidities.
• Failure of caudal block
• Diabetes mellitus
• Convulsions.
• Known allergy to any drugs used in this study.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexamethasone; Ondansetron; Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Abdelrahman Fathy Ahmed Mahny, resident doctor

CONTACT

+20 10 05086251; dr.3bdo202020@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12