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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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Key information

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

Dexamethasone

Drug

Primary outcomes

  1. 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

  2. number of rescue analgesic consumption

    Time frame: The first 24 hours after surgery

    Total number of rescue analgesic consumption for each patient

Secondary outcomes

  1. 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.

  2. 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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