Randomised control trial
Antevil, JaredTreatment of Suspected Symptomatic Cholelithiasis With Glycopyrrolate: A Prospective, Randomized Clinical Trial
Annals of Emergency Medicine
February 2005
- Submitted by:Travis Lien - ER resident
- Institution:Grand Rapids Medical Education and Research Center
- Date submitted:10th April 2006
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, to evaluate the efficacy of glycopyrrolate in the treatment of pain from suspected biliary colic
2
Design
2.1
Is the study design suitable for the objectives
Yes; randomized, double-blind, placebo-controlled trial
2.2
Who / what was studied?
A convenience sample of adult patients presenting to an emergency department with upper abdominal pain of suspected biliary tract origin, not relieved with a "GI cocktail"
2.3
Was this the right sample to answer the objectives?
Yes, although 42% of patients (16 of 38) had a normal gallbladder ultrasound
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
No, because of difficulty with patient enrollment, the trial was terminated before achievement of patient goal
2.5
Were all subjects accounted for?
Yes
2.6
Were all appropriate outcomes considered?
Yes, using the visual analog pain scale
2.7
Has ethical approval been obtained if appropriate?
Yes, approved by the IRB
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
Computer-generated sequence of randomization was designed prior to patient enrollment
2.10
Are the outcomes clinically relevant?
Yes
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes, 100 mm visual analog pain scale at 20 minute intervals
3.2
Are the measurements valid?
Yes, the primary outcome measure was the intergroup difference in pain measurement between 0 and 20 minutes
3.3
Are the measurements reliable?
Yes
3.4
Are the measurements reproducible?
Yes
3.5
Were the patients and the investigators blinded?
Yes, a nurse or medical technician not directly involved in the patient's care prepared the glycopyrrolate or normal saline for administration based on the computer-generated randomization
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Were groups comparable at baseline?
Yes, tables one and two demonstrate this
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes, figure two demonstrates this
4.5
Were side effects reported?
No
5
Analysis
5.1
Are the data suitable for analysis?
Yes, however this is limited due to convenience sampling and a small sample size
5.2
Are the methods appropriate to the data?
Yes
5.3
Are any statistics correctly performed and interpreted?
Yes, because of a non-normal data distribution, median differences in pain level were used
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes
6.2
Is the discussion biased?
No
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes, despite the limitations of the study, analysis failed to demonstrate any improvement in pain with glycopyrrolate
7.2
What level of evidence has this paper presented? (using CEBM levels)
2b
7.3
Does this paper help me answer my problem?
Yes
8
Implementation
8.1
Can any necessary change be implemented in practice?
Physicians should use analgesics with proven efficacy instead of glycopyrrolate in cases of suspected biliary colic
8.2
What aids to implementation exist?
Potential side-effects of glycopyrrolate and relative safety of other, more effective analgesics
8.3
What barriers to implementation exist?
Glycopyrrolate is inexpensive, easy to administer, and is proposed as an initial treatment option in several Emergency Medicine textbooks