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

Chor 2012.

Methods Location: Chicago, IL, USA
Recruitment time: from April 2007 to January 2010
Sample size calculation and the outcome of focus: Based on published literature, and assuming a SD of 23 mm, an alpha of 0.05 and power of 80%, a sample size of 37 participants in each group was calculated to detect a difference of 1.5 cm in the VAS assessment of pain at the time of IUD insertion.
Participants General with N: 87 women enrolled; 81 received IUDs
Source: University of Illinois Medical Center
Inclusion criteria: 18 years or older, desiring LNG‐IUS for contraception, without contraindications to using LNG‐IUS, without medical contraindications to NSAIDs, able to provide phone number for follow‐up questions, and had not taken pain medications on day of enrollment
Exclusion criteria: not reported
Interventions 1) Ibuprofen 800 mg
2) Placebo containing lactose
Timing: 45 min prior to IUD insertion
Outcomes Primary: Pain at time of tenaculum placement, pain at time of IUD insertion (10 cm VAS; 0 = no pain and 10 = unbearable)
Secondary: provider's ease of insertion
Notes IUC used: LNG‐IUS
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated, source not specified
Allocation concealment (selection bias) Low risk Both placebo and ibuprofen were identical in appearance, and were packaged in serially‐numbered envelopes and used in order.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants, providers and study recruiters were blinded to medication.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss to follow‐up: none