Karabayirli 2012.
Methods | Location: probably Turkey (location of investigators) Recruitment time: not reported Sample size calculation and outcome of focus: Based on initial pilot measurements, assuming SD within each group approximately 1.8, maximum difference of mean pain score (10‐point VAS) was 1.5, sample size of 29 in each group was calculated with power 80% and alpha .05 |
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Participants | General with N: 103 women Source: not reported; possibly university clinic Inclusion criteria: healthy (physical status ASA I) multiparous women of childbearing age (18 to 49 years), scheduled for IUD insertion Exclusion criteria: known allergy or hypersensitivity to NSAIDs or tramadol hydrochloride; current use of narcotic or NSAID; history of epilepsy, peptic ulcer disease, bleeding disorder, asthma, or hepatic or renal failure; nulliparity; delivery within 12 months, and breastfeeding at time of insertion |
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Interventions | 1) Naproxen sodium 550 mg (Apranax Fort tablets) 2) Tramadol HCl 50 mg (Contramal capsules) 3) Placebo (empty capsules) Timing: 1 h before insertion of IUD |
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Outcomes | Primary: pain score immediately after IUD insertion (10‐point VAS, with 10 meaning 'worst imaginable pain') Secondary: side effects, satisfaction and preference |
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Notes | IUC used: Multiload Cu 375 Standard | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and involved physicians of obstetrics and gynecology were blinded to the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: none |