RecruitingACTRN12616000957493

Effect of ondansetron on the duration of caudal block with bupivacaine on children who undergoing infraumbilical surgery

Effect of intravenously administered ondansetron on the duration and level of caudal block on pediatric patients whom ondergoing infraumbilical surgery


Sponsor

Baskent University

Enrollment

66 participants

Start Date

Jun 10, 2016

Study Type

Interventional

Conditions

Summary

Caudal epidural block is usually performing for pediatric patients whom underwent infraumbilical surgery. for postoperative analgesia. There are some publications showed that 5 HT-3 antagonist drugs like ondansetron, rapids sensorial block regression of neuroaxial anesthesia. We want to evaluate this effect on caudal block on pediatric patients. We include 4-10 years old ASA 1 or 2 patients who will undergo infraumbilical surgery. we will exclude if patients BMI is over 30 kg/m2, have neurological or neuromuscular disease, allergy to sudy drugs, have contrindication for caudal block. After routine monitorisation of patients and standart anesthetic induction for general anesthesia, we divide patients into two groups . We give 0.1 mg/kg ondansetron intravnously during seconds to Group Ondansetron and give same volume of serum physiologic for Group Control patients. After than we will perform caudal block with 1 ml/kg %0.025 bupivacaine at left decubitis position. After operation we will evaluate patients pain level with faces pain scale for 24 hours/ 1 time per hour and sensory level for 8 hours/ 1 time per hour. we will evaluate these findings and want to determine if there is a significant effect of ondansetron administration on the analgesic duration or sensorial level of caudal block.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 10 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for children aged 4 to 10 who are having surgery below the belly button (infraumbilical surgery). After surgery, children receive a nerve block (called a caudal block) to manage pain. This trial tests whether giving a common anti-nausea medication called ondansetron beforehand makes that nerve block last longer. You may be eligible if: - The child is between 4 and 10 years old - The child is scheduled for infraumbilical surgery - The child is in generally good health (ASA status 1 or 2) - The surgical plan includes a caudal nerve block for pain relief You may NOT be eligible if: - The family refuses participation - There is a medical reason the caudal block cannot be used - The child's BMI is over 30 - The child has a known allergy to ondansetron or bupivacaine - The child has a neurological or muscle disease Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

intravenous 0.1 mg/kg ondansetron in 30 seconds will given pediatric patients whom undergo infraumbilical surgery before immediately prior to caudal block. Caudal block will performed regardless of en

intravenous 0.1 mg/kg ondansetron in 30 seconds will given pediatric patients whom undergo infraumbilical surgery before immediately prior to caudal block. Caudal block will performed regardless of enrolment in this trial.


Locations(1)

Konya, Turkey

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ACTRN12616000957493