Stang 1997.
Methods | Prospective, randomized, double‐blind, placebo‐controlled trial Painful intervention: circumcision Study location: Fairview Riverside Medical Center, Minneapolis, Minnesota, USA Study period: 1993 to 1994 |
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Participants | 80 healthy term male newborns, mean PMA 39.5 weeks, mean PNA 31.5 h | |
Interventions | DPNB with non‐buffered lidocaine (0.8 mL lidocaine, 0.2 mL saline), new padded restraint chair and pacifier dipped in water (n = 20) DPNB with buffered lidocaine (0.8 mL lidocaine, 0.2 mL sodium bicarbonate), rigid plastic restraint chair and pacifier dipped in water (n = 20) DPNB with non‐buffered lidocaine (0.8 mL lidocaine, 0.2 mL saline), rigid plastic restraint chair and pacifier dipped in 24% sucrose (n = 20) DPNB with non‐buffered lidocaine (0.8 mL lidocaine, 0.2 mL saline), rigid plastic restraint chair and pacifier dipped in water (n = 20) |
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Outcomes | Behavioural Distress Scale (scores prior to injection, at injection for DPNB, 2 min post injection, 4 min post injection and at circumcision); plasma cortisol level (30 min after start of circumcision); percentage of sleep during circumcision | |
Notes | Results were reported as mean and SDs
ANOVA with repeated measures were used to compare distress scores. 1‐way ANOVAs were used to examine plasma cortisol and sleep data Adverse effects were not evaluated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Sucrose and water solutions blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessments |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data results did not specify number of infants with data |
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 |