Cırık 2013.
Methods | Location: Samsun, Turkey Recruitment time: December 2012 to March 2013 Sample size calculation and outcome of focus: not reported |
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Participants | General with N: 95 women Source: Samsun Maternity Hospital Inclusion criteria: 18 to 45 years old, presenting at hospital family planning unit for IUD insertion Exclusion criteria: lidocaine or copper allergy, uterine Mullerian anomalies, cervicitis, uterus bigger than 3 months of gestation, fibroids or polyps; had analgesic medication within 6 h of procedure or drug for cervical dilatation such as misoprostol; PID history in last 3 months; pregnancy within 6 weeks |
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Interventions | 1) 10 ml 1% lidocaine paracervical block 2) 10 mm 0.9% saline solution, paracervical injection 3) No analgesia Timing: 5 min before IUD insertion Injections: 5 ml at 3 o'clock and 5 ml at 9 o'clock positions of cervix |
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Outcomes | Primary: pain score immediately after tenaculum placement, immediately after IUD insertion, and 5 min after procedure; 10‐point VAS (0 = no pain to 10 = worst pain ever felt) Secondary: side effects |
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Notes | IUC used: CuT 380 | |
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 | High risk | Family Planning Unit providers were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: none |