Hypospadias, Postoperative Pain
Conditions
Keywords
Intravenous Dexamethasone, Pudendal nerve block, Analgesia, Postoperative pain, Children, Hypospadias
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.
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.
Interventions
DRUGDexamethasone
Sponsors
Dr Sonia ben khalifa (PhD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean time to first rescue analgesic | The first 24 hours after surgery | Time from the end of surgery to the first administration of rescue analgesic |
| number of rescue analgesic consumption | The first 24 hours after surgery | Total number of rescue analgesic consumption for each patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain scores (CHEOPS) | 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 | The first 24 hours after surgery | Number of episodes of postoperative nausea and vomiting in each patient |
Outcome results
None listed