Health Condition 1: K85- Acute pancreatitis
Conditions
Interventions
Intervention1: Parecoxib: 40 mg intravenously single dose followed by 20 mg at 12 hours interval for 5 days
Control Intervention1: Placebo: Equivalent volume of distilled water, initial bolus dose fol
Sponsors
Dr Pramod Kumar Garg
Eligibility
Inclusion criteria
Inclusion criteria: 1. Acute pancreatitis as defined by revised Atlanta classification. 2. The time interval from the onset of symptoms to presentation should be less than 7 days. 3. Systemic inflammatory response syndrome (SIRS) persisting for more than 24 hours.
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years or more than 70 years 2. Patients with Grade 2 or more organ failure as per Modified Marshallâ??s criteria. 3. Patients with a serum creatinine >1.4 mg/dl 4. Active or past history of GI bleeding or peptic ulcer disease 5. Patients with significant co-morbidity such as coronary artery disease, chronic kidney disease, cirrhosis, chronic obstructive airway disease, inflammatory bowel disease, and congestive heart failure or malignancy. 6. Patients who have history of bronchospasm, urticaria, angioneurotic edema or other allergic reactions to COX-2 inhibitors 7. Patients with evidence of chronic pancreatitis 8. Pregnancy and breast feeding 9. Failure to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Frequency of occurrence of persistent organ failure 2. Deterioration in OF score by one grade Timepoint: Four weeks or discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in APACHE II and SIRS scores 2. Duration of ICU stay and hospital stay 3. Reduction in the need for rescue analgesia 4. Reduction in level of CRP and inflammatory cytokines 5. Mortality within 30 days. 6. Adverse event such as gastrointestinal bleed, hypersensitivity reaction, renal impairment Timepoint: Four weeks or discharge | — |
Countries
India
Contacts
Public ContactDr Anugrah Dhooria
AIIMS New Delhi
Outcome results
None listed