Ahmed M Abbas1, Mohamed S Abdellah2, Mohamed Khalaf2, Mustafa Bahloul2, Noura H Abdellah3, Mohamed K Ali2, Ahmed M Abdelmagied2. 1. Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: bmr90@hotmail.com. 2. Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt. 3. Department of Pharmaceuticals, Faculty of Pharmacy, Assiut University, Assiut, Egypt.
Abstract
OBJECTIVE: The objective was to investigate the analgesic effect of cervical lidocaine-prilocaine (LP) cream in alleviating pain during copper T380A intrauterine device (IUD) insertion among parous women. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled trial at Assiut Women's Health Hospital, Egypt, from October 2015 to April 2016 of parous women desiring copper IUD insertion. We randomized the subjects in a 1:1 ratio to LP cream or placebo. Seven minutes prior to IUD insertion, women received 2 ml of LP cream or placebo to the anterior cervical lip, followed by 2 ml placed in the cervical canal using a Q-tip applicator. The study end point was the subjects' self-reported pain using a 10-cm visual analog scale (VAS) during cervical tenaculum placement, sound insertion, IUD insertion and 5 min postprocedure. We considered a 2-cm difference in VAS scores between study groups as clinically significant. Also, the difference in the ease of insertion score using a 10-cm VAS with 0=very easy insertion and 10=terribly difficult insertion was assessed. RESULTS: The study included 120 women (n=60 in each group). LP cream reduces the median VAS pain scores during tenaculum placement (2 vs. 4), sound insertion (3 vs. 6) and IUD insertion (3 vs. 6.5) with p=.0001 at all steps. A lower ease of insertion score was also determined among LP women (2.5±0.98 vs. 4.5±2.7, p=.001). Participants reported no side effects. CONCLUSIONS: Use of cervical LP cream prior to copper T380A IUD insertion may alleviate the IUD insertion pain among parous women. IMPLICATIONS: Cervical LP cream could be effective as an analgesic prior to copper T380A IUD insertion with no side effects. Further studies are needed to assess the women's satisfaction from lying with a speculum in place for 7 min while waiting for the cream to be effective.
RCT Entities:
OBJECTIVE: The objective was to investigate the analgesic effect of cervical lidocaine-prilocaine (LP) cream in alleviating pain during copperT380A intrauterine device (IUD) insertion among parous women. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled trial at Assiut Women's Health Hospital, Egypt, from October 2015 to April 2016 of parous women desiring copper IUD insertion. We randomized the subjects in a 1:1 ratio to LP cream or placebo. Seven minutes prior to IUD insertion, women received 2 ml of LP cream or placebo to the anterior cervical lip, followed by 2 ml placed in the cervical canal using a Q-tip applicator. The study end point was the subjects' self-reported pain using a 10-cm visual analog scale (VAS) during cervical tenaculum placement, sound insertion, IUD insertion and 5 min postprocedure. We considered a 2-cm difference in VAS scores between study groups as clinically significant. Also, the difference in the ease of insertion score using a 10-cm VAS with 0=very easy insertion and 10=terribly difficult insertion was assessed. RESULTS: The study included 120 women (n=60 in each group). LP cream reduces the median VAS pain scores during tenaculum placement (2 vs. 4), sound insertion (3 vs. 6) and IUD insertion (3 vs. 6.5) with p=.0001 at all steps. A lower ease of insertion score was also determined among LPwomen (2.5±0.98 vs. 4.5±2.7, p=.001). Participants reported no side effects. CONCLUSIONS: Use of cervical LP cream prior to copperT380A IUD insertion may alleviate the IUD insertion pain among parous women. IMPLICATIONS: Cervical LP cream could be effective as an analgesic prior to copperT380A IUD insertion with no side effects. Further studies are needed to assess the women's satisfaction from lying with a speculum in place for 7 min while waiting for the cream to be effective.