NCT Number: NCT03902249
Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain 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.
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Notify MeKey information
Conditions
Age range
1 year–18 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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
-
number of rescue analgesic consumption
Time frame: The first 24 hours after surgery
Total number of rescue analgesic consumption for each patient
Secondary outcomes
-
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.
-
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
Sponsors and collaborators
Lead sponsor
Dr Sonia ben khalifa (PhD)
Other
Registry information
Official study title
Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 4, 2019
- Registry last updated
- Apr 4, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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