Michelle Crawford1, Susan Davy2, Nicole Book2, John O Elliott2, Amol Arora2. 1. OhioHealth Riverside Methodist Hospital, Columbus, OH, USA. Electronic address: crawfordmichellek@gmail.com. 2. OhioHealth Riverside Methodist Hospital, Columbus, OH, USA.
Abstract
OBJECTIVE: To evaluate if oral ketorolac provides effective pain relief during placement of an IUD for contraception. METHODS: We conducted a double-blinded randomized controlled trial in a community hospital in Columbus, Ohio. Participants that met eligibility criteria were consented and randomized to receive either oral ketorolac 20 mg or placebo 40 to 60 minutes before IUD placement. Both participants and providers were blinded to the randomization group. The primary outcome was pain reduction (measured on a 0-10 numerical rating scale) during IUD placement. Data was analyzed using a two-sided independent samples t-test. An a priori sample size was calculated to detect a clinically meaningful difference of 2 points with 80% power. The type I error probability was α = 0.05. RESULTS:Seventy-two participants were enrolled and randomized between May 2014 until March 2016. Thirty-five in the ketorolac group and 36 in the placebo group were analyzed. There were no differences in baseline characteristics between participants or providers, as well as pain ratings prior to the procedure, at tenaculum placement, or at uterine sounding. There was a significant decrease in the pain of the ketorolac versus the placebo group rating at IUD deployment (4.2 vs. 5.7, P = 0.031), overall pain rating (3.6 vs. 4.9, P = 0.047), and pain 10 minutes after the procedure (1.1 vs, 2.5, P = 0.007). CONCLUSION:Oral ketorolac given 40 to 60 minutes prior to IUD insertion is effective in reducing pain during IUD deployment, overall pain, and pain 10 minutes after IUD placement.
RCT Entities:
OBJECTIVE: To evaluate if oral ketorolac provides effective pain relief during placement of an IUD for contraception. METHODS: We conducted a double-blinded randomized controlled trial in a community hospital in Columbus, Ohio. Participants that met eligibility criteria were consented and randomized to receive either oral ketorolac 20 mg or placebo 40 to 60 minutes before IUD placement. Both participants and providers were blinded to the randomization group. The primary outcome was pain reduction (measured on a 0-10 numerical rating scale) during IUD placement. Data was analyzed using a two-sided independent samples t-test. An a priori sample size was calculated to detect a clinically meaningful difference of 2 points with 80% power. The type I error probability was α = 0.05. RESULTS: Seventy-two participants were enrolled and randomized between May 2014 until March 2016. Thirty-five in the ketorolac group and 36 in the placebo group were analyzed. There were no differences in baseline characteristics between participants or providers, as well as pain ratings prior to the procedure, at tenaculum placement, or at uterine sounding. There was a significant decrease in the pain of the ketorolac versus the placebo group rating at IUD deployment (4.2 vs. 5.7, P = 0.031), overall pain rating (3.6 vs. 4.9, P = 0.047), and pain 10 minutes after the procedure (1.1 vs, 2.5, P = 0.007). CONCLUSION: Oral ketorolac given 40 to 60 minutes prior to IUD insertion is effective in reducing pain during IUD deployment, overall pain, and pain 10 minutes after IUD placement.