A comparative study to know the effect of diclofenac gel (used for pain relief) with diclofenac tablet (used for pain relief) in for breast pain.
- Conditions
- Health Condition 1: N644- Mastodynia
- Registration Number
- CTRI/2019/02/017635
- Lead Sponsor
- All India Institute of Medical Sciences Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All the females above 18 years presenting to the SOPD with cyclical or noncyclical mastalgia will be assessed for inclusion into the study. All patients with clinically or radiologically detected lump will be evaluated further by histopathological examination. All included patients will be evaluated radiologically by mammogram or ultrasound as indicated to exclude any associated pathology like malignancy/breast abscess/galactocele. The pain will be further evaluated for the need of pharmacological intervention. Only the patients with VAS score more than 5 will be included in the study. Rest will be managed with reassurance.
1.Age less than 18 year.
2.History of Allergy to diclofenac.
3.Known case of asthma, peptic ulcer disease, hepatic or renal dysfunction.
4.Any evidence of breast malignancy/ discrete breast lump.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain response as measured by Cardiff breast pain score after 7 days of treatment. <br/ ><br>Timepoint: 7 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.At the end of 30 days frequency of the need to use drug to remain pain free. <br/ ><br>2.Side effects leading to discontinuation of drug. <br/ ><br>3.Pain response as measured by Cardiff breast pain at the end of six month. <br/ ><br>4.Patient comfort level by using â??COMFORT DAISIESâ?? and preference of drug. <br/ ><br>Timepoint: 6 months