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Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair

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ClinicalTrials.gov Identifier: NCT03902249
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Hypospadias Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone group
Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline
Drug: Dexamethasone
Placebo Comparator: Placebo group
Patients who received the same volume of saline as the study group (8ml)
Drug: Dexamethasone



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Dr Sonia ben khalifa (PhD), Clinical Professor, Hôpital d'enfants Béchir-Hamza
ClinicalTrials.gov Identifier: NCT03902249     History of Changes
Other Study ID Numbers: DexaProtocol
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza:
Intravenous Dexamethasone
Pudendal nerve block
Analgesia
Postoperative pain
Children
Hypospadias
Additional relevant MeSH terms:
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Hypospadias
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action