1ST 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.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 METHODSSTUDY DESIGN:

Single-center

Prospective

Randomized

Double-blind

Placebo controlled trial.

MATERIALS AND METHODSSETTING:

Participants from ED of tertiary care universityH

All subjects provided written informed conesnt

Approved by both local and government ethics committees

MATERIALS AND METHODSINCLUSION 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 METHODSEXCLUSION CRETERIA:

Known allergies or contraindications to Rx.

Hemodynamic instability.

Fever T > 38C.

Peritoneal inflammation.

Pregnancy, aortic dissection/aneurysm.

Known organ failure.

MATERIALS AND METHODSINTERVENTIONS:

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 METHODSMETHODS 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 METHODSOUTCOME MEASURES:

**primary: change in visual scale.

**secondary: need for rescue analgesia at 30m.

Presence of at least 1 adverse event.

THE CRITICAL APPRAISAL

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 RESULTSHow large treatment effect?

How precise was the estimate of treatment effect?

WHAT ARE THE RESULTS

GROUPSOUTCOME

(YES)

OUTCOME

(NO)

TOTAL

CONT.

GP

ABA+B

EXPER.

GP

CDC+D

CONTROL EVENT RATE(CER) = A/A+BEXPER. EVENT RATE(EER) = C/C+DARR = EER-CERRRR = EER – DER/CERNNT = 1/ ARR

WHAT ARE THE RESULTS

WHAT ARE THE RESULTSStatistically significant reduction in pain comparing placebo to paracetamol with P=.005 and morphine with P=.045

No difference between paracetamol and morphine P=.74

WHAT ARE THE RESULTS

LIMITATIONSINTENTION TO TREAT ANALYSIS!!!

30mnts ED CARE!!!

ADVERSE EFFECT OR SYMPTOMS!!!

PLACEBO AND PAINFUL CONDITION!!!

APPLICABILITYFeasibility

Similarity in pts.

Potential benefits and harms.

Pts values and expectations

THANK YOU