Evaluate which PEG (4000 or 3350) is most preferred by children.Evaluate whether a preferable taste of the drug can lead to a better compliance and subsequently to a better success percentage of the treatment of childhood constipation.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters:
* PEG Preference (T=0)
* Constipation
* Compliance
Lemonade add-on is considered as a non-compliance towards the product when seen
in a frequency exceeding the 40%
Secondary outcome
Secondary outcome parameters
* Frequency of lemonade as an add-on
* Time required for administration of the drug
* PEG Preference (T= 4)
Background summary
Functional childhood constipation occurs in 6-30% of the children in the
western World. Nowadays polyethylene glycol (PEG) is becoming the first choice
drug for many paediatricians to treat constipation. The pediatricians can
choose from different PEG products PEG 4000 or PEG 3350. In general, it is
well/known that children do not like the taste of drugs. Few data in
constipated children show that PEG 4000 is better tolerated than Lactulose.
But a comparison of tolerance between two different PEG products in
constipated children has yet to be evaluated.
Our hypothesis is that compliance improves when children can choose (after
tasting) the medication themselves.
Study objective
Evaluate which PEG (4000 or 3350) is most preferred by children.
Evaluate whether a preferable taste of the drug can lead to a better compliance
and subsequently to a better success percentage of the treatment of childhood
constipation.
Study design
All children aged 4-12 and first seen in our outpatient clinic of the Emma
Children Hospital of the AMC presenting with functional constipation will be
asked for participation. After informed consent patients will be randomised to
either choose a PEG or to get one of the 2 PEGs (Forlax or Movicolon) in a dose
of 0.5 g/kg randomised by a computer programme.(4) All children and their
parents will be asked to complete a bowel diary to note the frequency of bowel
movements as well as symptoms like abdominal pain and nausea. The time taken to
administer the drug as well as the liquid in which the drug will be solved is
noted in the diary. Parents will be instructed to first try to solve the drug
in water. If the child refuses or it takes over an hour to administer the drug
they may solve it in lemonade. After 2 weeks we will evaluate the clinical
condition of the child by physical examination and by the information from the
bowel diaries. At week 4, children who did not choose at the start of the study
will also get the chance to taste a PEG and inform us about his/ her
preference. Also children who chose the drug at the start of the study will
again taste the drugs and give their preference. Besides tasting the drugs,
children will be examined and bowel diaries will be evaluated at week 4. This
third visit will be the end of this study. Children will further be treated in
our outpatient clinic for their complaints after completing the study.
Intervention
Not applicable
Study burden and risks
There is no burden for the patient. However, patients taste the PEGs once or
twice during a test requiring less than 5 minutes.
meibergdreef 9
1105 AZ
Nederland
meibergdreef 9
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
Functional constipation as defined by the Rome III criteria
Age 4-12 years
Exclusion criteria
Children who received PEG 4000 or PEG 3350 during the last 2 weeks before intake.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15052.018.07 |