Assesment the effect of Domperidone in the treatment of Functional Abdominal Pain in children

Comparison of the Effectiveness of Domperidon with Placebo in the treatment of Functional Abdominal Pain in children

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160308026973N2

Enrollment

Registered

2021-01-08

Start date

2021-01-20

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Abdominal Pain. Functional intestinal disorder, unspecified

Interventions

Intervention 1: Intervention group: Domperidone tablets 0.25mg / kg TDS up to 8 weeks (Hakim Pharmaceutical Company). Intervention 2: Control group: Placebo which is completely similar to Domperidone

Eligibility

Sex/Gender

All

Age

5 Years to 14 Years

Inclusion criteria

Inclusion criteria: 5-14 years old children referred to Amirkola Children's Hospital with diagnosis of functional abdominal pain (FAP)

Exclusion criteria

Exclusion criteria: Existence of chronic disease Taking other medications such as antibiotice and probiotic during the month before the start of the project The presence of Abdominal pain's red flags Constipation

Design outcomes

Primary

Measure	Time frame
Change at least 50% of the frequency of pain. Timepoint: At the beginning of the study and after two months of medication (end of the study). Method of measurement: Based on the questionnaire of reducing the frequency of pain, pain intensity and duration of pain (assessment of pain intensity based on face scale questionnaires).	—

Secondary

Measure	Time frame
Abdominal pain intensity based on Wong-Baker FACES Pain Rating Scale questionnaire. Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Wong-Baker FACES Pain Rating Scale questionnaire.;Duration of pain. Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Attached questionnaire at the end of the proposal (based on patient statements).;Pain frequency (number of pain days per month). Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Attached questionnaire at the end of the proposal (based on patient statements).	—

Measure

Time frame

Abdominal pain intensity based on Wong-Baker FACES Pain Rating Scale questionnaire. Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Wong-Baker FACES Pain Rating Scale questionnaire.;Duration of pain. Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Attached questionnaire at the end of the proposal (based on patient statements).;Pain frequency (number of pain days per month). Timepoint: At the beginning of the study (before the intervention) and after two months of medication (end of the study). Method of measurement: Attached questionnaire at the end of the proposal (based on patient statements).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Tavackoli Haghighi

Babol University of Medical Sciences

N.tavackoli.h@gmail.com+98 11 3235 4951

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026