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NCT Number: NCT06747975

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

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

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Key information

Conditions

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Although it has some adverse effects: postoperative nausea and vomiting (PONV) are frequent and morbidity-related complication in children, PONV is still present in almost twice the frequency of adults, 33.2-82%. shivering is one of frequent, undesirable adverse effects, The incidence of shivering is up to 40-60% even in regional anaesthesia leads to O2 consumption and CO2 production,So we target in this study two effective drugs with less side effects to reduse these adverse effects Ondansetron is a highly potent selective 5 hydroxytryptamine receptor antagonist, which is widely used as an anti-emetic, Its mechanism of action as anti-shivering is not clear and it is proposed to act centrally at the level of the pre-optic anterior hypothalamic region by inhibition of serotonin reuptake Dexamethasone: is a potent class of steroid drugs ,It prevents thermoregulatory shivering via its central inhibitory effect on the thermoregulatory center and prevents non thermoregulatory shivering by its anti-inflammatory activity, i.e. antagonizing the activation of the inflammatory responses and release of cytokines during surgery The anti-emetic properties of dexamethasone are well established but the mechanisms underlying this anti-emetic effect remain largely unknown

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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

Exclusion criteria

-

  • 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.

Treatment and study plan

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

Bupivacaine + saline

Drug

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

Primary outcomes

  1. the incidence of all emesis

    Time frame: 24 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Fathy Ahmed Mahny, resident doctor

CONTACT

[email protected]

+20 10 05086251

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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