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

Intussusception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02691858
• Other study ID #: CAIUNIPEDSURG-CR3
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: Mostafa Gad, MSc
• Phone: 201002265009
• Email: mostafagad[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 4 Years

Eligibility

Inclusion Criteria:

• Infantile Intussusception

Exclusion Criteria:

• Peritonitis Pneumoperitoneum Morbid patients

Related Conditions & MeSH terms

• Intussusception

Intervention

Drug:
• Hydrocortisone
10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
• Saline
100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

Locations

Country	Name	City	State
Egypt	Cairo University Pediatric Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Gersema, Lisa, and Karen Baker.

Kara CO, Kara IG. A measurement system for rhinoplasty patients. Kulak Burun Bogaz Ihtis Derg. 2003 Jan;10(1):45-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Pneumatic Reduction	Comparing number of Successful Pneumatic Reductions in both groups	1 Hour
Secondary	Reducing number of trials of Pneumatic Reduction	Comparing average number of Pneumatic Reduction trials between both groups	2 Hours
Secondary	Reducing complications	Comparing number of complications in both groups	2 Hours