Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion

Summary

A therapeutic abortion is one of the most common procedures performed in Canada, with approximately 100,000 occurring annually. 95% of induced abortions are done surgically, with just over two thirds of these procedures taking place in the first trimester. This study will be a randomized, controlled, double-blinded, single-centre superiority trial with three parallel groups; oral morphine vs intravenous fentanyl vs intravenous ketamine. The primary outcome will be immediate post-operative pain following a first trimester therapeutic abortion as assessed using the visual analogue scale. Randomization will be performed as block randomization with a 1:1:1 allocation ratio. In total, 123 participants will be recruited and randomized, with 41 being assigned to each treatment arm. This study will be conducted at the Women's Clinic at Kingston General Hospital in Kingston, Ontario, Canada. Women from Kingston and the surrounding areas are referred to this clinic and can self-refer for therapeutic abortion. The investogators hope that this research will move us towards a better form of pain control for our participants undergoing first trimester surgical abortion, without increasing length of stay, side effects, or adverse events. This, in turn, will hopefully improve access to optimal pain control to participants undergoing first trimester surgical abortion in an outpatient setting.

Timeline

Start

2019-06-10

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Background Induced abortions reported in Canada in 2016. Ottawa: Canadian Institute for Health Information; 2018. Available at: https://www.cihi.ca/en/induced-abortions-reported-in-canada-in-2016. Accessed on July 29, 2018.
• Background Costescu D, Guilbert E. No. 360-Induced Abortion: Surgical Abortion and Second Trimester Medical Methods. J Obstet Gynaecol Can. 2018 Jun;40(6):750-783. doi: 10.1016/j.jogc.2017.12.010.
• Background Allen RH, Fitzmaurice G, Lifford KL, Lasic M, Goldberg AB. Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):276-83. doi: 10.1097/AOG.0b013e3181938758.
• Background Agostini A, Maruani J, Roblin P, Champion J, Cravello L, Gamerre M. A double-blind, randomized controlled trial of the use of a 50:50 mixture of nitrous oxide/oxygen in legal abortions. Contraception. 2012 Jul;86(1):79-83. doi: 10.1016/j.contraception.2011.11.015. Epub 2012 Jan 20.
• Background Kan AS, Caves N, Wong SY, Ng EH, Ho PC. A double-blind, randomized controlled trial on the use of a 50:50 mixture of nitrous oxide/oxygen in pain relief during suction evacuation for the first trimester pregnancy termination. Hum Reprod. 2006 Oct;21(10):2606-11. doi: 10.1093/humrep/del234. Epub 2006 Jun 21.
• Background Strayer RJ, Nelson LS. Adverse events associated with ketamine for procedural sedation in adults. Am J Emerg Med. 2008 Nov;26(9):985-1028. doi: 10.1016/j.ajem.2007.12.005.
• Background Galloon S. Ketamine for dilatation and curettage. Can Anaesth Soc J. 1971 Nov;18(6):600-13. doi: 10.1007/BF03026180. No abstract available.
• Background Hejja P, Galloon S. A consideration of ketamine dreams. Can Anaesth Soc J. 1975 Jan;22(1):100-5. doi: 10.1007/BF03004825.
• Background Erbguth PH, Reiman B, Klein RL. The influence of chlorpromazine, diazepam, and droperidol on emergence from ketamine. Anesth Analg. 1972 Sep-Oct;51(5):693-700. No abstract available.
• Background Hervey WH, Hustead RF. Ketamine for dilatation and currettage procedures: patient acceptance. Anesth Analg. 1972 Jul-Aug;51(4):647-55.
• Background Krestow M. The effect of post-anaesthetic dreaming on patient acceptance of ketamine anaesthesia: a comparison with thiopentone-nitrous oxide anaesthesia. Can Anaesth Soc J. 1974 Jul;21(4):385-9. doi: 10.1007/BF03006072. No abstract available.
• Background Freuchen I, Ostergaard J, Kuhl JB, Mikkelsen BO. Reduction of psychotomimetic side effects of Ketalar (ketamine) by Rohypnol (flunitrazepam). A randomized, double-blind trial. Acta Anaesthesiol Scand. 1976;20(2):97-103. doi: 10.1111/j.1399-6576.1976.tb05015.x.
• Background Coad NR, Mills PJ, Verma R, Ramasubramanian R. Evaluation of blood loss during suction termination of pregnancy: ketamine compared with methohexitone. Acta Anaesthesiol Scand. 1986 Apr;30(3):253-5. doi: 10.1111/j.1399-6576.1986.tb02407.x.
• Background Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
• Background Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014 Feb;63(2):247-58.e18. doi: 10.1016/j.annemergmed.2013.10.015.
• Background Atkinson P, French J, Nice CA. Procedural sedation and analgesia for adults in the emergency department. BMJ. 2014 May 8;348:g2965. doi: 10.1136/bmj.g2965. No abstract available.
• Background Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011 May;57(5):449-61. doi: 10.1016/j.annemergmed.2010.11.030. Epub 2011 Jan 21.
• Background Newton A, Fitton L. Intravenous ketamine for adult procedural sedation in the emergency department: a prospective cohort study. Emerg Med J. 2008 Aug;25(8):498-501. doi: 10.1136/emj.2007.053421.
• Background Coralic Z, Sawe HR, Mfinanga JA, Cortez A, Koehl J, Siroker H, Reynolds TA. Ketamine procedural sedation in the emergency department of an urban tertiary hospital in Dar es Salaam, Tanzania. Emerg Med J. 2018 Apr;35(4):214-219. doi: 10.1136/emermed-2017-206974. Epub 2018 Jan 22.
• Background Bisanzo M, Nichols K, Hammerstedt H, Dreifuss B, Nelson SW, Chamberlain S, Kyomugisha F, Noble A, Arthur A, Thomas S. Nurse-administered ketamine sedation in an emergency department in rural Uganda. Ann Emerg Med. 2012 Apr;59(4):268-75. doi: 10.1016/j.annemergmed.2011.11.004. Epub 2011 Dec 9.
• Background Sacchetti A, Senula G, Strickland J, Dubin R. Procedural sedation in the community emergency department: initial results of the ProSCED registry. Acad Emerg Med. 2007 Jan;14(1):41-6. doi: 10.1197/j.aem.2006.05.023. Epub 2006 Aug 31.
• Background Allen RH, Singh R. Society of Family Planning clinical guidelines pain control in surgical abortion part 1 - local anesthesia and minimal sedation. Contraception. 2018 Jun;97(6):471-477. doi: 10.1016/j.contraception.2018.01.014. Epub 2018 Jan 31.

Drugs

Indications

No indication recorded.