Aksoy 2015.
Methods | Location: Kayseri, Turkey Recruitment time: December 2013 to January 2014 Sample size calculation and outcome of focus: pain with IUD insertion; reference values from published study. Assuming pain reduction by 0.5 SD was acceptable, at least 95 required in each arm to detect clinically significant difference between groups on 10 cm VAS scale when assuming 80% power to detect primary hypothesis and type I error of 0.05. Assuming 5% dropout, planned to recruit 200 (100 per study arm) |
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Participants | General with N: 200 parous women, 18 to 49 years old Source: family planning clinic at tertiary care center Inclusion criteria: age ≥ 18 years; accepting IUD as method of contraception; no known previous allergic reaction or sensitivity to lidocaine or placebo spray; no accompanying extraordinary medical or surgical conditions needing special attention; no specific request for anesthesia, or suspected pathology necessitating anesthesia; no history of chronic pelvic pain or dysmenorrhea Exclusion criteria: currently pregnant or within 2 weeks of pregnancy conclusion; presence of known uterine anomaly or fibroid distorting uterine cavity; contraindication to copper IUD based on CDC medical eligibility criteria; untreated acute cervicitis or PID; known cervical stenosis or extraordinary surgical conditions necessitating cervical dilators; any systemic diseases or medications that would affect perception of pain; current or past history of illegal drug or narcotic use; inability to understand how to score 10 cm VAS for pain; and VAS pain score other than 0 (no pain) just before IUD insertion |
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Interventions | 1) Lidocaine spray 10% (10 mg/mL); 4 pumps, with 3 to cervical surface and 1 toward cervical os (net 40 mg) 2) Saline spray placebo Timing: 3 min before tenaculum placement |
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Outcomes | Primary: pain during IUD insertion (10 cm VAS), assessed immediately after Secondary: no mention |
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Notes | IUC used: CuT 380A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number chart (via SPSS) |
Allocation concealment (selection bias) | Low risk | Consecutively numbered, sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Spray bottles wrapped in black paper. Sprays were identical in appearance, color, and consistency. Participants, anesthesia technician, and gynecologist performing procedure were blinded to bottle contents. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: none |