Nelson 2013.
Methods | Location: Los Angeles, CA, USA Recruitment time: from June 2008 to December 2008 Sample size calculation: Sample size arbitrarily selected for convenience to meet time and financial constraints in this investigator‐funded study. |
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Participants | General with N: 40 women Source: Women's Health Care Clinic (WHCC) at the Los Angeles Biomedical Research Institute at Harbor‐UCLA Medical Center Inclusion criteria: women identified as candidates for IUD use following clinic protocols, had given consent for IUD insertion and expressed interest in participating Exclusion criteria: not reported |
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Interventions | 1) 2% lidocaine (1.2 mL) infused into endometrial cavity (lower third, middle, and top of cavity) 2) Saline (1.2 mL) Timing: 3 min before IUD was inserted |
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Outcomes | Primary: pain score after tenaculum placement, after liquid infusion and IUD insertion, pain score of overall procedure (0 to 9 scale) Secondary: pain score comparisons by IUD types, prior IUD use, NSAID use, and by timing of placement during menses or not |
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Notes | IUC used: CuT 380A or LNG‐IUS 11 women took NSAIDs 15 min to 2 h prior to IUD insertion |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was done in a 1:1 ratio using a random number generator. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered and sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blinded" 2 clinicians who inserted IUDs were blinded to study group; participants apparently blinded. Research nurse placed study medication into tubing out of sight of provider and participant. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: none |