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

NCT ID: NCT04836962

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2022-01-31

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.

Conditions

Pediatric Patients Undergoing Hypospadias Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control

normal saline is administrated to patients.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

2cc of normal saline is administered to patient instead of dexamethasone.

dexamethasone

0.5mg/kg dexamethasone is administered to patients.

Group Type: EXPERIMENTAL

dexamethasone

Intervention Type: DRUG

dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.

Interventions

normal saline

2cc of normal saline is administered to patient instead of dexamethasone.

Intervention Type: DRUG

dexamethasone

dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeong-Rim Lee

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2021-0149

Identifier Type: -

Identifier Source: org_study_id