Pediatric Patients Undergoing Hypospadias Surgery
Conditions
Brief summary
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
Interventions
DRUGnormal saline
2cc of normal saline is administered to patient instead of dexamethasone.
DRUGdexamethasone
dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
6 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
1. pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery 2. American Society of Anesthesiologists (ASA) classification 1\ 2
Exclusion criteria
1. patients who are having uncorrected heart deformity 2. patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed 3. patients with blood coagulopathy 4. patients with diagnosed diabetes 5. patients with diagnosed adrenal disease 6. patients with fever above 37.5 degrees before surgery 7. patients currently taking steroids 8. patients contraindicated for dexamethasone administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the duration from surgery to first PCA(patient-controlled analgesia) administration | during 48 hours after surgery | the very first time of PCA usage after surgery, which is automatically recorded in PCA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the amount of additional analgesia required for postoperative 48hrs. | during 48 hours after surgery | the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA. |
| the number of additional analgesia required for postoperative 48hrs. | during 48 hours after surgery | the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA. |
| pain score for each time period | during 48 hours after surgery | ask parents about their children's pain score at each time point |
| overall parents' satisfaction questionnaire | 48 hours after surgery | at 48 hours after surgery, parents are asked about satisfaction of their children's pain control |
Countries
South Korea
Outcome results
None listed