Evaluation of Poly ethylene glycol and Lactulose effects on abdominal pain in children with fecal impaction and without ROME III criteria for constipation; (Occult constipation): a Randomized controlled study
Assessment of abdominal pain responding to Poly ethylene glycol vs Lactulose in patients with fecal impaction lacking ROME III criteria for constipation
Design
Pragmatic, community based, parallel group, double blind, randomised controlled trial
Settings and conduct
Patients were randomly stratified into two control and case groups. Case group was treated with Poly ethylene glycol for at least 2 weeks and control group was treated with Lactulose for at least 2 weeks. The abdominal pain was assessed by pain score scale from 1 to 10. Abdominal pain was assessed before and after treatment in both groups. Data was analysed using SPSS 23 software. Both participants and physicians were unaware of type of the prescribed medicine.
Participants/Inclusion and exclusion criteria
Inclusion criteria consists of patients at the age of 4 to 18 years, suffering from abdominal pain more than 14 days, and their abdominal pain lacks ROME III criteria for constipation. patients also have fecal impaction in abdominal X ray.
Exclusion criteria consists of patients with history of abdominal surgery, hematochezia, antibiotic or laxative consumption in the last 2 weeks.
Intervention groups
Patients with abdominal pain lacking ROME III criteria were randomly devided into two groups. One group was treated with Poly ethylene glycol and another group was treated with Lactulose.
Main outcome variables
Abdominal pain rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041966N1
Registration date:2018-12-22, 1397/10/01
Registration timing:retrospective
Last update:2018-12-22, 1397/10/01
Update count:0
Registration date
2018-12-22, 1397/10/01
Registrant information
Name
Mehran Hakimzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 9916
Email address
hakimmehran@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Poly ethylene glycol and Lactulose effects on abdominal pain in children with fecal impaction and without ROME III criteria for constipation; (Occult constipation): a Randomized controlled study
Public title
Effect of Poly ethylene glycol and Lactoluse on abdominal pain in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients at the age of 4 to 18 years
patients with abdominal pain more than 14 days
patients with abdominal pain lacking ROME III criteria for constipation
patients with fecal impaction in abdominal X ray
Exclusion criteria:
Abdominal surgery
Hematochezia
Antibiotic consumption in the last 2 weeks
Laxative consumption in the last 2 weeks
Age
From 4 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is simple and its unit is individual. The random sequence was carried out using random number table. Concealment was also carried out through similar drug containers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study has designed as double blind. The participants were unaware of the medicines, as their care givers were asked to give the patients the prepared medications; in form of solution or syrup in similar containers, making them unrecognizable from each other for patients. Meanwhile, the physicians who were assessing the patients abdominal pain had no knowledge of type of medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapor University of Medical Sciences
Street address
Abuzar hospital, Parastar Blv, Ahvaz city
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-12-15, 1397/09/24
Ethics committee reference number
IR.AJUMS.REC.1396.901
Health conditions studied
1
Description of health condition studied
abdominal pain in pediatrics
ICD-10 code
R10.9
ICD-10 code description
Unspecified abdominal pain
Primary outcomes
1
Description
56% of patients suffered from moderate abdominal pain
Timepoint
before intervention and 2, 3, 4, 5, 6, 8, 12 weeks after intervention
Method of measurement
pain score scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients were treated with Poly ethylene glycol powder (Sepidaj Company, Iran) dissolved in water, at dose of 0.5 gr/kg every 12 h orally for at least two consecutive weeks. Chemically, Poly ethylene glycol is a water-soluble polymer with high molecular weight.
Category
Treatment - Drugs
2
Description
Control group: The patients were treated with Lactulose Syrup (Tolid daru Company, Iran), at dose of 0.5 cc/kg every 12 h orally, for at least two consecutive weeks. Chemically, Lactulose is a synthetic disaccharide composed of galactose and glucose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abuzar hospital
Full name of responsible person
Mehran Hakimzade
Street address
Parastar Blv, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3443 9916
Email
hakimmehran@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad Badavi
Street address
Shahre Daneshgahi, Ahavz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Hakimzade
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Abuzar hospital, Parastar Blv., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3443 9916
Email
hakimmehran@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Hakimzade
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Abuzar hospital, Parastar Blv, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3443 9916
Email
hakimmehran@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Hakimzade
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Abuzar hospital, Parastar Blv, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3443 9916
Email
hakimmehran@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available