Caudal Dexamethasone - Bupivacaine in Neonates

May 20, 2026 updated by: sawsan haridy ahmed aboelhassan, Ain Shams University

Analgesic Efficacy Of Dexamethasone As Adjuvant To Caudal Bupivacaine For Neonates Undergoing Inguinal Hernia Repair: Randomized Controlled Study

Randomied controlled study Evaluate the effects of caudal Dexamethasone in neonates

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Evaluate the additive analgesic effects of caudal Dexamethasone in neonates undergoing inguinal hernia repair.

additive side effects if found

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • full term neonate
  • ASA I & ASA II
  • Scheduled for inguinal hernia repair

Exclusion Criteria:

  • Patients with allergies to studied drugs
  • body weight <3 kilograms
  • parents refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone - Bupivacaine group
Add Dexamethasone to Bupivacaine in caudal anesthesia in neonate
Procedure: We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group
We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonates undergoing inguinal hernia repair
Other: Saline - Bupivacaine group
Control group to the other arm of the study
Procedure: We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group
We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonates undergoing inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC pain scale (face,leg , activity,cry, consolability) in the first 24 hours postoperative
Time Frame: 6 months
Assessment for additive analgesic effects of caudal Dexamethasone
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • O6U-ERC-0136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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