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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-12
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 2 to 12 years old.

Patients with stable vital signs.

Patients with normal laboratory investigations.

Patients undergoing Caudal anaesthesia for infraumbilical surgeries

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: group AExperimental treatment 2 interventions
Group B: group BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

the incidence of all emesis

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

Time frame
24 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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