Ngo 2014.
Methods | Location: San Diego, CA, USA Recruitment time: July 2012 to May 2013 Sample size calculation and outcome of focus: not reported |
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Participants | General with N: 67 women Source: university medical center Inclusion criteria: nulliparous and multiparous women ages 18 to 50, English‐ or Spanish‐speaking, presenting for IUD insertion for contraception or menorrhagia (in the case of Mirena IUD insertion) Exclusion criteria: pregnancy, any diagnosed pain issues, if the patient has taken any pain medications within 6 h of enrollment (including aspirin or other NSAIDs), misoprostol within 24 h of enrollment, history of prior IUD insertion, known allergy to NSAIDs (including diagnosis of aspirin or NSAID‐induced asthma or urticaria), known contraindications to NSAIDs (including bile acid sequestrants, cyclosporine, drotrecogin, floctafenine, lithium, methotrexate, pentoxifylline, probenecid, rivaroxaban, SSRIs, warfarin), renal insufficiency, peptic ulcer disease or history of significant gastrointestinal bleeding, known thrombocytopenia, known coagulopathy, or known bleeding disorder, and known contraindications to IUD |
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Interventions | 1) Ketorolac (Toradol) injection (30 mg, 1 cc volume) 2) Placebo 0.9% normal saline injection (1 cc volume) Timing: 30 min prior to IUD insertion |
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Outcomes | Primary: pain score with IUD insertion 5 min after insertion and 15 min after insertion (10 cm VAS) Secondary: side effects and satisfaction (assessed, according to ClinicalTrials.gov listing, but not in abstract) |
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Notes | IUC used: LNG‐IUS; unclear whether copper‐containing IUD also used Information from conference abstract and ClinicalTrial.gov listing |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |