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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902249
• Other study ID #: DexaProtocol
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Hôpital d'enfants Béchir-Hamza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypospadias
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr Sonia ben khalifa (PhD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean time to first rescue analgesic	Time from the end of surgery to the first administration of rescue analgesic	The first 24 hours after surgery
Primary	number of rescue analgesic consumption	Total number of rescue analgesic consumption for each patient	The first 24 hours after surgery
Secondary	pain scores (CHEOPS)	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
Secondary	Number of episodes of postoperative nausea and vomiting	Number of episodes of postoperative nausea and vomiting in each patient	The first 24 hours after surgery