Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
Primary Purpose
Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High dose dexamethasone
Low dose dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy focused on measuring caudal block, low dose dexamethasone, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Dexamethasone
Arm Description
Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study
Lower, antiemetic dose of dexamethasone (0.15mg/kg)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to the first additional analgesic
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
total number of additional analgesic
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
pain score at each time point
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
scale of satisfaction at each time point
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04841018
Brief Title
Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
Official Title
Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
August 29, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
Keywords
caudal block, low dose dexamethasone, postoperative pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Lower, antiemetic dose of dexamethasone (0.15mg/kg)
Intervention Type
Drug
Intervention Name(s)
High dose dexamethasone
Intervention Description
After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone
Intervention Type
Drug
Intervention Name(s)
Low dose dexamethasone
Intervention Description
After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone
Primary Outcome Measure Information:
Title
The need for additional analgesics during the first 48 hrs after surgery
Description
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.
Time Frame
Until 48 hours after the surgery
Secondary Outcome Measure Information:
Title
Time to the first additional analgesic
Description
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Time Frame
Until 48 hours after the surgery
Title
total number of additional analgesic
Description
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Time Frame
Until 48 hours after the surgery
Title
pain score at each time point
Description
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Time Frame
Until 48 hours after the surgery
Title
scale of satisfaction at each time point
Description
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Time Frame
Until 48 hours after the surgery
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Rim Lee
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
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