- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902249
Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair
April 2, 2019 updated by: Dr Sonia ben khalifa (PhD)
Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018).
After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair.
Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline.
The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV.
The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision.
No analgesics were administered at the end of the surgery.
The pain was assessed by the CHEOPS score the first 24 hours.
The X2 test was used for qualitative variables and the student test for quantitative variables with P<0.
05 as the significance threshold.
The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- ASA physical status classification 1 or 2
- Procedure: hypospadias repair
- Eligible for a pudendal nerve block
Exclusion Criteria:
- parents or patient refusal
- nerve block failure
- Peroperative complication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexamethasone group
Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline
|
|
Placebo Comparator: Placebo group
Patients who received the same volume of saline as the study group (8ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean time to first rescue analgesic
Time Frame: The first 24 hours after surgery
|
Time from the end of surgery to the first administration of rescue analgesic
|
The first 24 hours after surgery
|
number of rescue analgesic consumption
Time Frame: The first 24 hours after surgery
|
Total number of rescue analgesic consumption for each patient
|
The first 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain scores (CHEOPS)
Time Frame: Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
|
CHEOPS score ranges from 4 to 13. 13 is the worst score.
If the score was superior to 7 rescue analgesia was administrated.
|
Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
|
Number of episodes of postoperative nausea and vomiting
Time Frame: The first 24 hours after surgery
|
Number of episodes of postoperative nausea and vomiting in each patient
|
The first 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 4, 2019
Study Record Updates
Last Update Posted (Actual)
April 4, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Urogenital Abnormalities
- Congenital Abnormalities
- Penile Diseases
- Pain, Postoperative
- Hypospadias
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- DexaProtocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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