Bednarek 2013.
Methods | Location: Portland Oregon, USA Recruitment time: December 2010 to June 2011 Sample size calculation and the outcome of focus: Assuming one‐sided alpha of 0.05, pooled SD 28 mm and power 82%, a sample size of 12 in each group was calculated to detect 30 mm pain score difference between groups. |
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Participants | General with N: 24 nulliparous women Source: academic medical clinic and local family planning clinic Inclusion criteria: nulliparous women, age 18 to 45 years, requesting LNG‐IUS for contraception Exclusion criteria: previous pregnancy > 20 weeks; previous IUD placement or attempted placement; contraindication to nitroprusside or LNG‐IUS; history of migraine, cluster or vascular headaches; blood pressure < 90/55 or > 150/100 at beginning of study visit |
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Interventions | 1) 10 mg nitroprusside, 1% aqueous gel 2) Placebo gel Timing: immediately prior to IUD placement |
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Outcomes | Primary: pain score at tenaculum placement, with IUD insertion, and 30 min post‐insertion (100 mm VAS with 0 = no pain and 100 = worst imaginable pain) Secondary: side effects, satisfaction (100 mm VAS) |
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Notes | IUC used: LNG‐IUS | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization list, source not specified |
Allocation concealment (selection bias) | Low risk | Study drug prepared and packaged at a separate site |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and all study staff involved in the care of the participant were blinded to study arm allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: none |