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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Intussusception

Treatments

Drug: Hydrocortisone
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02691858
CAIUNIPEDSURG-CR3

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

3 months to 4 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infantile Intussusception

Exclusion criteria

  • Peritonitis Pneumoperitoneum Morbid patients

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Hydrocortisone
Experimental group
Description:
Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Treatment:
Drug: Hydrocortisone
Saline
Placebo Comparator group
Description:
Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Treatment:
Drug: Saline

Trial contacts and locations

1

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Central trial contact

Mahmoud Elfiky, MD; Mostafa Gad, MSc

Data sourced from clinicaltrials.gov

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