Health Condition 1: N644- Mastodynia
Conditions
Interventions
Intervention1: Diclofenac gel: Apply locally over affected breast tid for 7 days then SOS.
Maximum duration for 6 months
Control Intervention1: Diclofenac tablet: 50 mg tid for 7 days then SOS.
Maximu
Sponsors
All India Institute of Medical Sciences Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain response as measured by Cardiff breast pain score after 7 days of treatment. Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At the end of 30 days frequency of the need to use drug to remain pain free. 2. Side effects leading to discontinuation of drug. 3. Pain response as measured by Cardiff breast pain at the end of six month. 4. Patient comfort level by using â??COMFORT DAISIESâ?? and preference of drug. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactPradeep Kumar Singh
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed