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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone group | Active Comparator | Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline |
|
| Placebo group | Placebo Comparator | Patients who received the same volume of saline as the study group (8ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| number of rescue analgesic consumption | Total number of rescue analgesic consumption for each patient | The first 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of episodes of postoperative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38627668 | Derived | Khalifa SB, Slimene AB, Blaiti H, Kaddour R, Hassen AF, Pardessus P, Brasher C, Dahmani S. The potentiating effect of intravenous dexamethasone upon preemptive pudendal block analgesia for hypospadias surgery in children managed with Snodgrass technique: a randomized controlled study : Dexamethasone for pain management in children. BMC Anesthesiol. 2024 Apr 16;24(1):145. doi: 10.1186/s12871-024-02536-3. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007021 | Hypospadias |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Number of episodes of postoperative nausea and vomiting in each patient |
| The first 24 hours after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |