Health Condition 1: null- Recurrent abdominal pain
Conditions
Interventions
Intervention1: 1. Drotaverine hydrochloride suspension (5mg/10 ml)
2. Drotaverine hydrochloride tablet (40 mg): 1. For children aged between 4 to 6 years, 10 mL of the drotaverine hydrochloride susp
Sponsors
Walter Bushnell Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged between 4 to 12 years of either gender with RAP or non-organic abdominal condition (defined as at least three episodes of pain interfering with normal activities within a three month period). 2. Children whose parents/legal guardians give written informed consent prior to the study entry. 3. Children with good health as determined by: • Medical history • Physical examination • Clinical judgment of the investigator
Exclusion criteria
Exclusion criteria: 1. Established organic etiology of abdominal pain (e.g. chronic pancreatitis, cholelithiasis, nephro/urolithiasis, inflammatory bowel disease) 2. Cognitive-developmental delay or cerebral palsy 3. Had previous abdominal surgery 4. Any evidence of acute illness or infection 5. Children with known immunosuppression/immunodeficiency 6. Children with history of anaphylaxis, or any serious drug reaction, or allergy to any drug component 7. Children with any clinical evidence of other chronic diseases such as cardiac, hepatic or renal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures 1. Number of episodes of pain/spasm during 4 weeks of use of drug/placebo. 2. Number of pain free days (maintenance of spasmolysis) 3. Onset of pain relief Timepoint: Daily for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in abdominal pain (frequency/severity) according to the VAS score after 5, 12 and 30 minutes of drug/placebo. 2. Number of school days missed during the study period 3. Parental satisfaction (on a Likert scale) 4. Occurrence of adverse effects (e.g. vertigo, nausea or vomiting) Timepoint: At the end of 4 weeks | — |
Countries
India
Contacts
Public ContactDr Manish Narang
University College of Medical Sciences & Guru Teg Bahadur Hospital Hospital
Outcome results
None listed