Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception

Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial

Sponsors

Lead Sponsor: Cairo University

Source Cairo University
Brief Summary

Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception.

Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.

Detailed Description

Experimental group will be given single dose IV Hydrocortisone 10 mg/kg with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Control group will be given Saline 100 ml IV single injection with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Overall Status Recruiting
Start Date April 2015
Completion Date December 2020
Primary Completion Date June 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Success of Pneumatic Reduction 1 Hour
Secondary Outcome
Measure Time Frame
Reducing number of trials of Pneumatic Reduction 2 Hours
Reducing complications 2 Hours
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hydrocortisone

Description: 10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

Arm Group Label: Hydrocortisone

Other Name: Solu-Cortef

Intervention Type: Drug

Intervention Name: Saline

Description: 100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

Arm Group Label: Saline

Other Name: sodium chloride 0.9%

Eligibility

Criteria:

Inclusion Criteria:

- Infantile Intussusception

Exclusion Criteria:

- Peritonitis Pneumoperitoneum Morbid patients

Gender: All

Minimum Age: 3 Months

Maximum Age: 4 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gamal El Tagy, MD Study Chair Cairo University
Overall Contact

Last Name: Mostafa Gad, MSc

Phone: 201002265009

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Cairo University Pediatric Hospital Mahmoud Elfiky, MD [email protected] Mostafa Gad, MD Principal Investigator
Location Countries

Egypt

Verification Date

January 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: Mahmoud El Fiky

Investigator Title: Lecturer of Pediatric Surgery

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Hydrocortisone

Type: Experimental

Description: Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction

Label: Saline

Type: Placebo Comparator

Description: Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov