Skip to main content
. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3

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
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
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
Outcomes Primary: pain score immediately after IUD insertion (10‐point VAS, with 10 meaning 'worst imaginable pain')
Secondary: side effects, satisfaction and preference
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