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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intussusception

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infantile Intussusception Exclusion Criteria: Peritonitis Pneumoperitoneum Morbid patients

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br>Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction | Drug: Hydrocortisone<br>* 10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction<br>* Other names: Solu-Cortef;|
| Placebo Comparator: Saline<br>Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction | Drug: Saline<br>* 100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction<br>* Other names: sodium chloride 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Pneumatic Reduction | Comparing number of Successful Pneumatic Reductions in both groups | 1 Hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing number of trials of Pneumatic Reduction | Comparing average number of Pneumatic Reduction trials between both groups | 2 Hours | 
| Reducing complications | Comparing number of complications in both groups | 2 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intussusception