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1 ST JOURNAL CLUB. Dr.Raihana AL-Anqoudi. OUTLINE. ABOUT THE ARTICLE METHOD AND MATERIALS CRITICAL APPRAISAL LIMITATIONS. IV paracetamol or morphine for Rx of renal colic. IV paracet. Or morph Rx renal c.
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1ST JOURNAL CLUB Dr.Raihana AL-Anqoudi
OUTLINE ABOUT THE ARTICLE METHOD AND MATERIALS CRITICAL APPRAISAL LIMITATIONS
IV paracet. Or morph Rx renal c. From department of emergency medicine and department of radiology, akdeniz university, Turkey. Annals of emergency medicine, volume54, October 2009.
IV paracet. Or morph Rx renal c. Renal colic intensely painful condition. Opioids and NSAIDs both used to relieve pain and both have adverse effects. Paracetamol is safe and effective analgesic tested in post op pain but not in renal colic.
IV paracet. Or morph Rx renal c. THE GOAL: To determine the analgesic efficacy and safety of single-dose of iv paracetamol versus morphine versus placebo for pts presenting to ED with renal colic.
MATERIALS AND METHODS STUDY DESIGN: Single-center Prospective Randomized Double-blind Placebo controlled trial.
MATERIALS AND METHODS SETTING: Participants from ED of tertiary care universityH All subjects provided written informed conesnt Approved by both local and government ethics committees
MATERIALS AND METHODS INCLUSION CRETERIA: • Age 18-55 yrs. • Clinical diagnosis of suspected renal colic • Mild or more pain intensity( point 4 on verbal scale and 20 out of 100 on visual analogue scale)
MATERIALS AND METHODS EXCLUSION CRETERIA: Known allergies or contraindications to Rx. Hemodynamic instability. Fever T > 38C. Peritoneal inflammation. Pregnancy, aortic dissection/aneurysm. Known organ failure.
MATERIALS AND METHODS INTERVENTIONS: Subjects randomized in 1:1:1 ratio. Study drugs identical in color and appearance, premixed by a study nurse and administered by another blinded nurse.
MATERIALS AND METHODS METHODS OF MEASUREMENT: * Pain reported on 100mm visual scale and 4 points verbal rating scale. *Recorded before Rx, at 15mnts and at 30mnts. * Adverse events collected.
MATERIAL AND METHODS OUTCOME MEASURES: ** primary: change in visual scale. **secondary: need for rescue analgesia at 30m. Presence of at least 1 adverse event.
ARE RESULTS VALID • Assignment randomized? • All pts accounted for at its conclusion? • Complete follow up? • Pt analyzed in groups randomized? • Pts, health care workers, blinded? • Similar groups at start? • Groups treated equally?
WHAT ARE THE RESULTS How large treatment effect? How precise was the estimate of treatment effect?
WHAT ARE THE RESULTS CONTROL EVENT RATE(CER) = A/A+B EXPER. EVENT RATE(EER) = C/C+D ARR = EER-CER RRR = EER – DER/CER NNT = 1/ ARR
WHAT ARE THE RESULTS Statistically significant reduction in pain comparing placebo to paracetamol with P=.005 and morphine with P=.045 No difference between paracetamol and morphine P=.74
LIMITATIONS INTENTION TO TREAT ANALYSIS!!! 30mnts ED CARE!!! ADVERSE EFFECT OR SYMPTOMS!!! PLACEBO AND PAINFUL CONDITION!!!
APPLICABILITY Feasibility Similarity in pts. Potential benefits and harms. Pts values and expectations