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

Dr Sonia ben khalifa (PhD)

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Hypospadias

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03902249

DexaProtocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Male

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

Dexamethasone group

Active Comparator group

Description:

Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline

Treatment:

Drug: Dexamethasone

Placebo group

Placebo Comparator group

Description:

Patients who received the same volume of saline as the study group (8ml)

Treatment:

Drug: Dexamethasone