title: Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial.
abstract: OBJECTIVE
  Rectal nonsteroidal anti-inflammatory drugs have been shown to reduce the incidence of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The aim of this study was to determine whether intramuscular diclofenac reduces the risk of PEP.
  
  
  METHODS
  Patients who underwent ERCP were randomized to receive either 90 mg of diclofenac or placebo by intramuscular injection immediately after the procedure. PEP was defined as elevated serum amylase levels (at least three times the upper limit of normal 24 hours after the procedure) associated with new or worsened upper abdominal, epigastric, or back pain.
  
  
  RESULTS
  In total, 380 patients were randomized, and 343 were eligible for analysis. The two groups were similar regarding clinical and demographic factors, as well as patient- and procedure-related risk factors for PEP. PEP developed in 20/170 patients (11.8 %) in the placebo group and in 22/173 patients (12.7 %) in the diclofenac group (P = 0.87). Multivariate regression analysis failed to illustrate that intramuscular diclofenac prevented PEP (odds ratio 0.79; 95 % confidence interval 0.39 - 1.25; P = 0.51).
  
  
  CONCLUSIONS
  Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP.Clinicaltrials.gov NCT01717599.
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Hallym University College of Medicine, Seoul, Korea.
authors.forename: Se Woo
authors.initials: SW
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Moon Jae
authors.initials: MJ
authors.lastname: Chung
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Tak Geun
authors.initials: TG
authors.lastname: Oh
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jeong Youp
authors.initials: JY
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Seungmin
authors.initials: S
authors.lastname: Bang
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Si Young
authors.initials: SY
authors.lastname: Song
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000627:therapeutic use; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004008:Diclofenac / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015994:Incidence; D007273:Injections, Intramuscular; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac