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. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3

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.
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
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
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
Notes IUC used: CuT 380A or LNG‐IUS
11 women took NSAIDs 15 min to 2 h prior to IUD insertion
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