NCT04841018

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

2.4 years

First QC Date

March 30, 2021

Last Update Submit

September 12, 2023

Conditions

Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy

Keywords

caudal blocklow dose dexamethasonepostoperative pain

Outcome Measures

Primary Outcomes (1)

  • The need for additional analgesics during the first 48 hrs after surgery

    The child's parent is to be educated prior to the surgery so that when the pain score (FLACC or Wong-Baker Faces Scale) is 4 or above at home, he or she receives an additional acetaminophen. The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to assess the need for additional analgesics until 48 hours after the surgery.

    Until 48 hours after the surgery

Secondary Outcomes (4)

  • Time to the first additional analgesic

    Until 48 hours after the surgery

  • total number of additional analgesic

    Until 48 hours after the surgery

  • pain score at each time point

    Until 48 hours after the surgery

  • scale of satisfaction at each time point

    Until 48 hours after the surgery

Study Arms (2)

Control

EXPERIMENTAL

Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study

Drug: High dose dexamethasone

Dexamethasone

EXPERIMENTAL

Lower, antiemetic dose of dexamethasone (0.15mg/kg)

Drug: Low dose dexamethasone

Interventions

High dose dexamethasoneDRUG

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

Control
Low dose dexamethasoneDRUG

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

Dexamethasone

Eligibility Criteria

Age6 Months - 6 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages from 6 months old to 6 years old
  • Body weight Less than or equal to 16.7kg
  • American Society of Anesthesiologists (ASA) classification I or II
  • Patients receiving orchiopexy under general anesthesia

You may not qualify if:

  • Patients with uncorrected cardiac anomalies
  • Patients with vertebral anomalies
  • Diagnosis of diabetes mellitus
  • Diagnosis of adrenal disease
  • Currently on steroid
  • Body temperature above 37.5'C preoperatively
  • Allergy to dexamethasone
  • Laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jeong-Rim Lee

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients enrolled are allocated into one of the following two groups: control group (group C) who receive a higher dose of dexamethasone known to enhance the effect of caudal block from previous study (0.5mg/kg) and dexamethasone group (group D) who receive a lower, antiemetic dose of dexamethasone (0.15mg/kg)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 12, 2021

Study Start

March 24, 2021

Primary Completion

August 29, 2023

Study Completion

September 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)