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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02691858
Other study ID # CAIUNIPEDSURG-CR3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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