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

NCT04836962 | Completed

• 1 other identifier: 4-2021-0149
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• the duration from surgery to first PCA(patient-controlled analgesia) administration

  the very first time of PCA usage after surgery, which is automatically recorded in PCA.

  during 48 hours after surgery

Secondary Outcomes (4)

• the amount of additional analgesia required for postoperative 48hrs.

  during 48 hours after surgery

• the number of additional analgesia required for postoperative 48hrs.

  during 48 hours after surgery

• pain score for each time period

  during 48 hours after surgery

• overall parents' satisfaction questionnaire

  48 hours after surgery

Study Arms (2)

control

PLACEBO COMPARATOR

normal saline is administrated to patients.

Drug: normal saline

dexamethasone

EXPERIMENTAL

0.5mg/kg dexamethasone is administered to patients.

Drug: dexamethasone

Interventions

normal saline DRUG

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

control

dexamethasone DRUG

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

dexamethasone

Eligibility Criteria

• Age: 6 Months - 3 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
• American Society of Anesthesiologists (ASA) classification 1\~2

You may not qualify if:

• patients who are having uncorrected heart deformity
• patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
• patients with blood coagulopathy
• patients with diagnosed diabetes
• patients with diagnosed adrenal disease
• patients with fever above 37.5 degrees before surgery
• patients currently taking steroids
• patients contraindicated for dexamethasone administration

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Saline Solution; Dexamethasone

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jeong-Rim Lee

  Department of Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 7, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)