This study is a randomized double blind trial that evaluates oral Paraffin and Polyethylene Glycol (PEG) in treatment of children with chronic functional constipation. Inclusion criteria include: all children aged 2 to 12 years with chronic functional constipation according to Rome III diagnostic criteria. Exclusion criteria include: have an organic constipation, gastrointestinal surgery and history of drug use. The sample size was calculated 160 and the study population was children aged 2-12 years with chronic functional constipation that referred to gastroenterology clinic at Mousavi Hospital in Zanjan. The patients randomly were divided into two groups. The first group was given PEG solution with dose 1 cc/kg/day (equivalent 0.8 gr/kg/day of powdered PEG) orally in two divided doses for 6 months and the second group was given Paraffin solution with dose 1 cc/kg/day orally in two divided doses for 6 months. The children were followed up once a week for first month and then monthly up to 6 months. On follow up period the therapeutic response such the number of defecation per week, stool consistency, rectal bleeding, painful defecation, fecal incontinence (Encopresis), abdominal pain and adverse effects were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091618971N2
Registration date:2014-10-01, 1393/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-01, 1393/07/09
Registrant information
Name
Kambiz Eftekhari
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3000
Email address
k-eftekhari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The research department of Zanjan University of Medical Sciences.
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Oral paraffin and Polyethylene Glycol (PEG) in treatment of children with chronic functional constipation.
Public title
Compare the treatment of constipation in children with paraffin and polyethylene glycol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: all children aged 2 to 12 years with chronic functional constipation according to Rome III diagnostic criteria.
Exclusion criteria include: have an organic constipation such as Hirschsprung's disease; hyporthyroidism; cardiac; renal and neurologic disorders; history of gastrointestinal surgery and drug use especially anticonvulsants; sedatives and antidepressants.
Age
From 2 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Zanjan
City
Zanjan
Postal code
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
ZUMS.REC.1392.81
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified
Primary outcomes
1
Description
The number of bowel movements per week
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
2
Description
Stool consistency
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
3
Description
Painful defecation
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
Secondary outcomes
1
Description
Rectal bleeding
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
2
Description
Fecal incontinence
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
3
Description
Abdominal pain
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
4
Description
The side effects of treatment
Timepoint
Once a week during the first month, then every month until 6 months
Method of measurement
History
Intervention groups
1
Description
The first group was given PEG solution with dose 1 cc/kg/day (equivalent 0.8 gr/kg/day of powdered PEG) orally in two divided doses for 6 months.
Category
Treatment - Drugs
2
Description
The second group was given Paraffin solution with dose 1 cc/kg/day orally in two divided doses for 6 months.