Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?

Yonsei University

Status: Completed

Conditions: Pediatric Patients Undergoing Hypospadias Surgery

Treatments: Drug: dexamethasone; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04836962

4-2021-0149

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Male

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

normal saline is administrated to patients.

Treatment:

Drug: normal saline

dexamethasone

Experimental group

Description:

0.5mg/kg dexamethasone is administered to patients.

Treatment:

Drug: dexamethasone