Taddio 2011.
| Methods | RCT Painful intervention: venipuncture Study location: Mother and Infant Unit, Mount Sinai Hospital, Toronto, Ontario, Canada Study period: 20 August 2007 to 22 February 2009 |
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| Participants | 330 infants mean PMA (SD) 39.5 weeks (1.2) Liposomal lidocaine group (n = 110) mean PMA (SD) 39.6 weeks (1) Sucrose group (n = 110) mean PMA (SD) 39.6 weeks (1.3) Sucrose liposomal lidocaine group (n = 110) mean PMA (SD) 39.6 weeks (1.3) |
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| Interventions | Liposomal lidocaine group: 1 g liposomal lidocaine 4% cream to the dorsum of the hand, occluded by a dressing (Tegaderm) for 30‐40 min Sucrose group: 2 mL 24% sucrose solution, administered by mouth using a syringe over 1‐2 min Sucrose liposomal lidocaine group: both sucrose and liposomal lidocaine as described above Placebos were used for liposomal lidocaine and sucrose (i.e. double‐dummy design), so that all infants received a topically administered cream (liposomal lidocaine or placebo cream) and oral solution (sucrose or placebo water) |
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| Outcomes | Facial grimacing, cry duration (s),observer‐rated pain using a visual analogue scale (VAS) (0 to 10 cm), HR (beats/min), oxygen saturation (%) | |
| Notes | Reported no significant adverse effects | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table used |
| Allocation concealment (selection bias) | Low risk | Concealment of treatment allocation was achieved by carrying out randomization and dispensing functions offsite |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and personnel blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Efficacy outcomes were not reported in 9 infants and safety outcomes were not repotted in 2 infants |
| Selective reporting (reporting bias) | Unclear risk | The study protocol was not available to us so we could not judge whether there were any deviations from it |
| Other bias | Low risk | Appears free of other bias |