Role of Drotaverine hydrochloride in children with recurrent abdominal pai
- Conditions
- Health Condition 1: null- Recurrent abdominal pain
- Registration Number
- CTRI/2012/07/002765
- Lead Sponsor
- Walter Bushnell Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures <br/ ><br>1.Number of episodes of pain/spasm during 4 weeks of use of drug/placebo. <br/ ><br>2.Number of pain free days (maintenance of spasmolysis) <br/ ><br>3. Onset of pain relief <br/ ><br>Timepoint: Daily for 4 weeks
- Secondary Outcome Measures
Name Time Method 1.Change in abdominal pain (frequency/severity) according to the VAS score after 5, 12 and 30 minutes of drug/placebo. <br/ ><br>2.Number of school days missed during the study period <br/ ><br>3.Parental satisfaction (on a Likert scale) <br/ ><br>4.Occurrence of adverse effects (e.g. vertigo, nausea or vomiting) <br/ ><br>Timepoint: At the end of 4 weeks