Selby 1995.
Methods | Randomized controlled 4‐arm parallel trial at a metropolitan hospital in the UK | |
Participants | 160 unpremedicated women, American Society of Anesthesiologists (ASA) grade 1 or 2, requiring insertion of an intravenous cannula for general anaesthetic Excluded if allergies to local anaesthetics, or analgesic medication taken in last 4 hours Groups (40 in each) were similar in terms of age, weight, visibility of veins and anxiety levels |
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Interventions | Group 1: no local anaesthetic Group 2: 0.2 mL of EMLA cream rubbed into the skin over the vein and covered with a non‐absorbent dressing for 5 minutes before cannulation Group 3: ethyl chloride sprayed over the vein for 10 seconds from a height of 20 cm, with cannulation performed immediately Group 4: 0.2 mL of 1% lignocaine injected subcutaneously at the site of venepuncture with a 25 gauge (G) needle, and left for 30 seconds before cannulation |
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Outcomes | Anxiety, difficulty of cannulation, number of failed cannulations, pain during local anaesthetic application, pain of cannulation, pain 1 minute after cannulation | |
Funding | None declared | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated" Method not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Manuscript reports 2 different set of figures for the first attempt success rate. This ranged from 38 to 40 out of 40 for the control group, and from 36 to 37 for the ethyl chloride group |
Selective reporting (reporting bias) | Unclear risk | Protocol not described, but all expected outcomes described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |