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Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?

NCT04841018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2023-09-14

No results posted yet for this study

Summary

Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.

Conditions

  • Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy

Interventions

DRUG

High dose dexamethasone

After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone

DRUG

Low dose dexamethasone

After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jeong-Rim Lee · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2023-08-29
Completion
2023-09-01

Countries

  • South Korea

Study Locations

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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 NCT04841018 on ClinicalTrials.gov