Back to resultsDoes the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
Primary Purpose
Pediatric Patients Undergoing Hypospadias Surgery
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
normal saline
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Patients Undergoing Hypospadias Surgery
Eligibility Criteria
Inclusion Criteria:
- pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
- American Society of Anesthesiologists (ASA) classification 1~2
Exclusion Criteria:
- patients who are having uncorrected heart deformity
- patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
- patients with blood coagulopathy
- patients with diagnosed diabetes
- patients with diagnosed adrenal disease
- patients with fever above 37.5 degrees before surgery
- patients currently taking steroids
- patients contraindicated for dexamethasone administration
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control
dexamethasone
Arm Description
normal saline is administrated to patients.
0.5mg/kg dexamethasone is administered to patients.
Outcomes
Primary Outcome Measures
the duration from surgery to first PCA(patient-controlled analgesia) administration
the very first time of PCA usage after surgery, which is automatically recorded in PCA.
Secondary Outcome Measures
the amount of additional analgesia required for postoperative 48hrs.
the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
the number of additional analgesia required for postoperative 48hrs.
the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
pain score for each time period
ask parents about their children's pain score at each time point
overall parents' satisfaction questionnaire
at 48 hours after surgery, parents are asked about satisfaction of their children's pain control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04836962
Brief Title
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
Official Title
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (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
No
5. Study Description
Brief Summary
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Patients Undergoing Hypospadias Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
normal saline is administrated to patients.
Arm Title
dexamethasone
Arm Type
Experimental
Arm Description
0.5mg/kg dexamethasone is administered to patients.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
2cc of normal saline is administered to patient instead of dexamethasone.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.
Primary Outcome Measure Information:
Title
the duration from surgery to first PCA(patient-controlled analgesia) administration
Description
the very first time of PCA usage after surgery, which is automatically recorded in PCA.
Time Frame
during 48 hours after surgery
Secondary Outcome Measure Information:
Title
the amount of additional analgesia required for postoperative 48hrs.
Description
the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
Time Frame
during 48 hours after surgery
Title
the number of additional analgesia required for postoperative 48hrs.
Description
the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
Time Frame
during 48 hours after surgery
Title
pain score for each time period
Description
ask parents about their children's pain score at each time point
Time Frame
during 48 hours after surgery
Title
overall parents' satisfaction questionnaire
Description
at 48 hours after surgery, parents are asked about satisfaction of their children's pain control
Time Frame
48 hours after surgery
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
American Society of Anesthesiologists (ASA) classification 1~2
Exclusion Criteria:
patients who are having uncorrected heart deformity
patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
patients with blood coagulopathy
patients with diagnosed diabetes
patients with diagnosed adrenal disease
patients with fever above 37.5 degrees before surgery
patients currently taking steroids
patients contraindicated for dexamethasone administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Rim Lee
Organizational Affiliation
Department of Anesthesiology and Pain Medicine
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
Learn more about this trial
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
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