Introduction: A single-hand Paragard® intrauterine system (IUS) inserter was investigated for insertion and safety. The objective of this sub-analysis is to explore patient reported pain during placement of a copper intrauterine device (IUD).

Methods: In this phase four, multicenter clinical study, a total of 117 subjects underwent an IUS placement attempt with the redesigned inserter. Patients reported pain scores on an 11- point Likert scale (0-10) immediately after: speculum placement, tenaculum placement, uterine sounding, and IUD insertion attempt. Analgesia was administered at the discretion of the investigator.

Results: In 117 placement attempts, the mean pain scores for all steps of IUD insertion were in the mild range 0-5 (1.3-4.1). Similar pain scores and placement success were seen in nulliparous and parous patients. Investigators utilized cervical dilation in 41% of patients (mechanical 36%, misoprostol 5%) and analgesics in 59% of patients (oral analgesia 26%, cervical block or topical analgesia 46%) with some patients receiving more than one analgesic. No significant differences in reported pain based on dilation or use/type of medication were observed. Perceived pain at insertion was not affected by uterine positioning, nor was pain correlated with clinician reported ease of insertion. The only factor identified to be correlated with pain score at insertion was the pain reported at the sounding phase of procedure.

Conclusion: In this study, perception of pain during IUD insertion is an individualized experience and is not significantly impacted by analgesic or patient characteristics but may be influenced by patient pain tolerance or anticipation.