Anzctr.org.au
Analgesia following LNG-IUS insertion, a randomised controlled trial: vaginal Diazepam vs placebo. Project Team Roles & ResponsibilitiesPrincipal InvestigatorDr Emma Readman, Director of Endosurgery B Unit Mercy Hospital for WomenAssociate InvestigatorsDr Madeleine Smith Project Coordinator Responsible for recruitment, data collection and analysis Dr Lauren Hicks, Endosurgery FellowProject creation, recruitment and review of publicationDr Lenore Ellett, Director of Endosurgery A Unit Direction in study design and preparation for publicationDr Samantha Mooney, Consultant GynaecologistProject creation, recruitment and review of publicationBackgroundLevonorgestral-releasing intrauterine devices (LNG-IUS), such as the Mirena (Bayer), are being increasingly prescribed in Australia ADDIN EN.CITE <EndNote><Cite><Author>Bingham</Author><Year>2018</Year><RecNum>29</RecNum><DisplayText>(1)</DisplayText><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582855741">29</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bingham, Amie L.</author><author>Garrett, Cameryn C.</author><author>Bayly, Christine</author><author>Kavanagh, Anne M.</author><author>Keogh, Louise A.</author><author>Bentley, Rebecca J.</author><author>Hocking, Jane S.</author></authors></contributors><titles><title>The levonorgestrel intrauterine device in Australia: analysis of prescribing data 2008–2012</title><secondary-title>BMC Women's Health</secondary-title></titles><periodical><full-title>BMC Women's Health</full-title></periodical><pages>194</pages><volume>18</volume><number>1</number><dates><year>2018</year><pub-dates><date>2018/11/27</date></pub-dates></dates><isbn>1472-6874</isbn><urls><related-urls><url>;(1). Despite their proven efficacy in contraceptionPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MdXVra2FpbmVuPC9BdXRob3I+PFllYXI+MTk5NTwvWWVh
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ADDIN EN.CITE.DATA (2), heavy menstrual bleeding ADDIN EN.CITE <EndNote><Cite><Author>Magon</Author><Year>2013</Year><RecNum>28</RecNum><DisplayText>(3)</DisplayText><record><rec-number>28</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582855697">28</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Magon, Navneet</author><author>Chauhan, Monica</author><author>Goel, Poonam</author><author>Malik, Sonia</author><author>Kapur, Krishan</author><author>Kriplani, Alka</author><author>Dhaliwal, Lakhbir</author><author>Pandit, Suchitra N.</author></authors></contributors><titles><title>Levonorgestrel intrauterine system: Current role in management of heavy menstrual bleeding</title><secondary-title>Journal of mid-life health</secondary-title><alt-title>J Midlife Health</alt-title></titles><periodical><full-title>Journal of mid-life health</full-title><abbr-1>J Midlife Health</abbr-1></periodical><alt-periodical><full-title>Journal of mid-life health</full-title><abbr-1>J Midlife Health</abbr-1></alt-periodical><pages>8-15</pages><volume>4</volume><number>1</number><keywords><keyword>AUB</keyword><keyword>heavy menstrual bleeding</keyword><keyword>hysterectomy</keyword><keyword>levonorgestrel intrauterine system</keyword><keyword>menorrhagia</keyword><keyword>mirena</keyword><keyword>skyla</keyword></keywords><dates><year>2013</year></dates><publisher>Medknow Publications & Media Pvt Ltd</publisher><isbn>0976-7800
0976-7819</isbn><accession-num>23833527</accession-num><urls><related-urls><url>;(3) and pelvic pain ADDIN EN.CITE <EndNote><Cite><Author>Bahamondes</Author><Year>2007</Year><RecNum>30</RecNum><DisplayText>(4)</DisplayText><record><rec-number>30</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582855790">30</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bahamondes, L.</author><author>Petta, C. A.</author><author>Fernandes, A.</author><author>Monteiro, I.</author></authors></contributors><auth-address>Human Reproduction Unit, Department of Obstetrics and Gynecology, School of Medicine, Universidade Estadual de Campinas (UNICAMP), 13084-971, Campinas, SP, Brazil. bahamond@caism.unicamp.br</auth-address><titles><title>Use of the levonorgestrel-releasing intrauterine system in women with endometriosis, chronic pelvic pain and dysmenorrhea</title><secondary-title>Contraception</secondary-title></titles><periodical><full-title>Contraception</full-title></periodical><pages>S134-9</pages><volume>75</volume><number>6 Suppl</number><edition>2007/05/29</edition><keywords><keyword>Dysmenorrhea/*drug therapy</keyword><keyword>Endometriosis/*drug therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Intrauterine Devices, Medicated</keyword><keyword>Levonorgestrel/*administration & dosage</keyword><keyword>Pelvic Pain/drug therapy</keyword><keyword>Progestins/*administration & dosage</keyword><keyword>Randomized Controlled Trials as Topic</keyword></keywords><dates><year>2007</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0010-7824 (Print)
0010-7824</isbn><accession-num>17531605</accession-num><urls></urls><electronic-resource-num>10.1016/j.contraception.2006.12.008</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(4), overall population usage remains low. One of the contributing factors to this is thought to be fear around pain with and following IUD insertion ADDIN EN.CITE <EndNote><Cite><Author>Claringbold</Author><Year>2019</Year><RecNum>31</RecNum><DisplayText>(5)</DisplayText><record><rec-number>31</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582855829">31</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Claringbold, L.</author><author>Sanci, L.</author><author>Temple-Smith, M.</author></authors></contributors><titles><title>Factors influencing young womens contraceptive choices</title><secondary-title>Australian Journal for General Practitioners</secondary-title></titles><periodical><full-title>Australian Journal for General Practitioners</full-title></periodical><pages>389-394</pages><volume>48</volume><dates><year>2019</year><pub-dates><date>05/23</date></pub-dates></dates><publisher>The Royal Australian College of General Practitioners (RACGP)</publisher><urls><related-urls><url>;(5). 59% of nulliparous women reported moderate to severe pain in the first 24 hours following LNG-IUD insertion, reducing to 31% from 24-72 hoursPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYWxsPC9BdXRob3I+PFllYXI+MjAxNjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (7). Studies assessing possible methods to reduce post-insertion pain have shown mixed results ADDIN EN.CITE <EndNote><Cite><Author>Gemzell-Danielsson</Author><Year>2013</Year><RecNum>34</RecNum><DisplayText>(8)</DisplayText><record><rec-number>34</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582856560">34</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gemzell-Danielsson, K.</author><author>Mansour, D.</author><author>Fiala, C.</author><author>Kaunitz, A. M.</author><author>Bahamondes, L.</author></authors></contributors><auth-address>Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, SE-17176 Stockholm, Sweden. kristina.gemzell@ki.se</auth-address><titles><title>Management of pain associated with the insertion of intrauterine contraceptives</title><secondary-title>Hum Reprod Update</secondary-title></titles><periodical><full-title>Hum Reprod Update</full-title></periodical><pages>419-27</pages><volume>19</volume><number>4</number><edition>2013/05/15</edition><keywords><keyword>Abortion, Induced</keyword><keyword>Analgesics/therapeutic use</keyword><keyword>Anesthesia, Local</keyword><keyword>Anti-Inflammatory Agents, Non-Steroidal/therapeutic use</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hysteroscopy</keyword><keyword>Intrauterine Devices/*adverse effects</keyword><keyword>*Pain Management</keyword><keyword>Pelvic Pain/drug therapy/*etiology/*prevention & control</keyword><keyword>analgesia</keyword><keyword>cervical priming</keyword><keyword>intrauterine contraception</keyword><keyword>local anaesthesia</keyword><keyword>pain</keyword></keywords><dates><year>2013</year><pub-dates><date>Jul-Aug</date></pub-dates></dates><isbn>1355-4786</isbn><accession-num>23670222</accession-num><urls></urls><custom2>PMC3682672</custom2><electronic-resource-num>10.1093/humupd/dmt022</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(8). Misoprostol insertion may reduce pain with insertion, however it causes increased pre-insertion cramps and no difference in cramping 24 hours post insertion ADDIN EN.CITE <EndNote><Cite><Author>Scavuzzi</Author><Year>2013</Year><RecNum>35</RecNum><DisplayText>(9)</DisplayText><record><rec-number>35</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582856574">35</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Scavuzzi, Adriana</author><author>Souza, Alex S.R.</author><author>Costa, Aurélio A.R.</author><author>Amorim, Melania M.R.</author></authors></contributors><titles><title>Misoprostol prior to inserting an intrauterine device in nulligravidas: a randomized clinical trial</title><secondary-title>Human Reproduction</secondary-title></titles><periodical><full-title>Human Reproduction</full-title></periodical><pages>2118-2125</pages><volume>28</volume><number>8</number><dates><year>2013</year></dates><isbn>0268-1161</isbn><urls><related-urls><url>;(9). NSAIDs have been shown to be beneficial in the management of post-insertion pain ADDIN EN.CITE <EndNote><Cite><Author>Grimes</Author><Year>2006</Year><RecNum>36</RecNum><DisplayText>(10)</DisplayText><record><rec-number>36</rec-number><foreign-keys><key app="EN" db-id="vxst992f5s2f0ne99z7v90r22t9xdeeaasef" timestamp="1582856900">36</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Grimes, D. A.</author><author>Hubacher, D.</author><author>Lopez, L. M.</author><author>Schulz, K. F.</author></authors></contributors><titles><title>Non‐steroidal anti‐inflammatory drugs for heavy bleeding or pain associated with intrauterine‐device use</title><secondary-title>Cochrane Database of Systematic Reviews</secondary-title></titles><periodical><full-title>Cochrane Database of Systematic Reviews</full-title></periodical><number>2</number><keywords><keyword>Anti‐Inflammatory Agents, Non‐Steroidal [*therapeutic use]</keyword><keyword>Dysmenorrhea [*drug therapy, etiology]</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Intrauterine Devices [*adverse effects]</keyword><keyword>Menorrhagia [*drug therapy, etiology]</keyword><keyword>Randomized Controlled Trials as Topic</keyword></keywords><dates><year>2006</year></dates><publisher>John Wiley & Sons, Ltd</publisher><isbn>1465-1858</isbn><accession-num>CD006034</accession-num><urls><related-urls><url>;(10).Vaginal administration of diazepam has been proposed as a treatment for pelvic floor muscle spasmPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYXJyaWNvPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48
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ADDIN EN.CITE.DATA (13) while allowing local administration. Oral preparations are currently being evaluated (), however, to our knowledge, no data exists on the impact of vaginal Diazepam administration following IUD insertion.Our aim is to evaluate the impact of a dose of vaginal diazepam following insertion of the Mirena IUD in an outpatient setting on pelvic pain and cramping. We hypothesize that patients will experience a reduction in post-insertion pain compared to placebo.Project DesignDouble-blinded, placebo-controlled, randomized controlled trialSite Mercy Hospital for Women, HeidelbergIntervention armsInsertion of 10mg vaginal diazepam pessary or identical placebo immediately following LNG-IUD placement in an outpatient settingRandomisation1:1 randomisation to active and placebo treatment with stratification based on parity (nulliparous vs multiparous)ParticipantsWomen undergoing elective outpatient insertion of LNG-IUSInclusion CriteriaPremenopausal Nulliparous or multiparousAvailability of carer to drive patient home from appointmentAccess to a computer and email account for completion of questionnairesWritten English language proficiency to provide consent and complete questionnairesExclusion CriteriaAllergy or contraindication to diazepam or pessary componentsContraindication to outpatient insertion of IUDPostnatal <6/52 or breastfeedingSample size calculationSample size calculations have been based on the reported incidence of pain at 24 hours following IUD insertion reported by Hall et al 2016. They used a 4-point pain scale at this time point (no pain, mild pain, moderate pain, severe pain).We plan to use a 5-point pain scale (no, mild, moderate, severe, extreme) in our data collectionSample size required to detect a reduction in primary outcome by one third (from 59% to 39%), with 80% power and 0.05 type 1 error97 participants in each group, 194 totalAim to recruit 120 participants in each group to allow for loss to follow-upRecruitmentPatients booked for an outpatient LNG-IUD insertion will be approached for participationA phone-call will be made by a member of the research team informing the patient of the study and gauging interest in participation This phone call will occur at least 1 week prior to the scheduled appointmentIf the patient agrees to participate in the study a PCIF form will be sent via email to the patient through the red cap data base system Script for Phone Contact I am a doctor/nurse from the Mercy Hospital for Women contacting you on as you have been booked for an outpatient Mirena insertion and have indicated that you may be interested in participating in a research project. Before we begin would you mind confirming your full name, date of birth and address? Our research team are looking at trialling a new medication to manage pain post insertion of Mirena, in the hope that in the future we can make awake Mirena insertion a more comfortable process for all women. Is this something you are interested in hearing more about? In order to be included in this study you should no longer be breast feeding and would need someone to drive you home following the procedure. You will also need to have access to an email account so that we are able to contact you easily following your Mirena insertion. This medication used in this study is called diazepam and is usually used as a tablet to treat muscle spasm pain. The aim of the research project is to see weather using this medication reduces the cramping some women experience after Mirena insertion. Common side effects of this medication include drowsiness and light-headedness. As part of this research study participants would receive a vaginal pessary as part of the Mirena insertion process. This pessary will contain either diazepam or a placebo. Neither you nor the doctor will know if placebo or diazepam has been administered at the time. The pharmacy will be aware which medication has been given and can provide this information to your doctor if needed. This will not significantly prolong the length of the procedure. Study participants will then be contacted via email and asked to complete a short questionnaire regarding pain levels at day 1, day 3 and day 7 following insertion. If this is something you would be interested in participating in, or would like to hear more about, I can email you a document with more detailed information. After carefully reading through this information, if you would like to participate you will need to complete and return a consent form. COVID Safe Plan Adherence to Hospital based COVID protocols As applicable at time of patient contact (Note these may vary from current protocols)Patient screening at presentation to hospital Use of surgical masks by both doctor and patient Limiting presence of a support person when possible Intervention should not prolong time of patient/doctor contact This study does not require any additional hospital visits or clinician contact beyond what is required for medical care Recruitment for study will occur via phone contact Consent process should be completed prior to patient presentation to hospital if possible. Where not possible, there will be no additional hospital visit requiredFollow up via telehealth/email contact Data collection (participant commitment, duration and follow-up):Time-pointsDay of LNG-IUD insertionBaseline data collection including patient demographics, reason for insertion, pre-insertion pain assessmentPost-insertion questionnaire assessing experience of insertionDay 1 post-insertionEmail to patient Questionnaire to assess pain in first 24 hours following insertion and any adverse effects from treatmentEstimated time to complete: 10 minutesDay 3 post-insertionEmail to patient Questionnaire to assess pain in 24-72 hours following insertion and any adverse effects from treatmentEstimated time to complete: 10 minutesDay 7 post-insertionEmail to patient Questionnaire to assess pain in first week following insertion and any adverse effects from treatmentEstimated time to complete: 10 minutesFollow-up phone call if no/incomplete response to day 3 and 7 questionnaires3 Months post-insertionRoutine clinic reviewQuestionnaire to assess patient satisfaction and discontinuation rate (can be provided via email if in-person review does not occur)Data Collection and StorageDemographic data will be collected from patient medical records at the Mercy Hospital for Women and patient questionnaireAssessment immediately following insertion will be collected via paper-based questionnairePatient email questionnaires will be administered via REDCap online database management softwareAll collected data will be securely stored on MHW servers using the REDCap systemData analysisData will be analysed with the assistance of a trained statisticianPre-defined subgroup analyses of indication for LNG-IUD insertion (pelvic pain or dysfunctional uterine bleeding) and parity are proposedOutcome measuresPrimary outcome: Moderate, severe or extreme pain in first 24 hours after LNG-IUD insertionSecondary outcomes:Median pain scale response in first 24 hours post-insertion (using non-parametric analysis of ordinal data)Moderate, severe or extreme pain 24-72 hours post-insertionWorst pain in 1 week following insertionDiscontinuation rate at 3 months’ following insertionAdverse effects of treatmentInvestigational DrugDiazepamManufacturer: Healthsmart Pharmacy and Compounding Parkville Approved therapeutic indications: anxiety disorder, alcohol withdrawal, muscle spasm, spasticity, athetosisMode of action: activation of gamma-aminobutyric acid resulting in anxiolytic, sedative, muscle relaxant and anticonvulsant effectsDosage regime: 10mg vaginal pessary as single doseExcretion: Primarily urinary excretion of metabolitesContraindications: Hypersensitivity to benzodiazepines, COPD with respiratory failure, severe respiratory insufficiency, sleep apnoea, myasthenia gravis, CNS depressant dependenceAdverse effects: sedation, fatigue, muscle weakness, ataxia, tolerance/dependence with prolonged useIn line with TGA requirements, patients recruited will have a script for the trial drug or placebo faxed to the manufacturer. Randomisation will be performed using , with stratification for parity, and the appropriate blinded medication will be posted to the hospital for administration after Mirena insertionResults, Outcomes and Future PlansDissemination of resultsTo participantsParticipants will not be routinely unblinded at the completion of the studyParticipants with a serious adverse event will be immediately unblindedParticipants may contact the study coordinator after completion of the study if they wish to know their treatment groupPublicationsResults for this study are planned to be submitted to a peer-reviewed journalFollow-up researchThe participant cohort may be approached for further research at 5 years after insertion to assess for long-term LNG-IUD discontinuation rateReferences ADDIN EN.REFLIST 1.Bingham AL, Garrett CC, Bayly C, Kavanagh AM, Keogh LA, Bentley RJ, et al. The levonorgestrel intrauterine device in Australia: analysis of prescribing data 2008–2012. BMC Women's Health. 2018;18(1):194.2.Luukkainen T, Toivonen J. Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception. 1995;52(5):269-76.3.Magon N, Chauhan M, Goel P, Malik S, Kapur K, Kriplani A, et al. Levonorgestrel intrauterine system: Current role in management of heavy menstrual bleeding. J Midlife Health. 2013;4(1):8-15.4.Bahamondes L, Petta CA, Fernandes A, Monteiro I. Use of the levonorgestrel-releasing intrauterine system in women with endometriosis, chronic pelvic pain and dysmenorrhea. Contraception. 2007;75(6 Suppl):S134-9.5.Claringbold L, Sanci L, Temple-Smith M. Factors influencing young womens contraceptive choices. Australian Journal for General Practitioners. 2019;48:389-94.6.Hall AM, Kutler BA. Intrauterine contraception in nulliparous women: a prospective survey. J Fam Plann Reprod Health Care. 2016;42(1):36-42.7.Grunloh DS, Casner T, Secura GM, Peipert JF, Madden T. Characteristics associated with discontinuation of long-acting reversible contraception within the first 6 months of use. Obstet Gynecol. 2013;122(6):1214-21.8.Gemzell-Danielsson K, Mansour D, Fiala C, Kaunitz AM, Bahamondes L. Management of pain associated with the insertion of intrauterine contraceptives. Hum Reprod Update. 2013;19(4):419-27.9.Scavuzzi A, Souza ASR, Costa AAR, Amorim MMR. Misoprostol prior to inserting an intrauterine device in nulligravidas: a randomized clinical trial. Human Reproduction. 2013;28(8):2118-25.10.Grimes DA, Hubacher D, Lopez LM, Schulz KF. Non‐steroidal anti‐inflammatory drugs for heavy bleeding or pain associated with intrauterine‐device use. Cochrane Database of Systematic Reviews. 2006(2).11.Carrico DJ, Peters KM. Vaginal diazepam use with urogenital pain/pelvic floor dysfunction: serum diazepam levels and efficacy data. Urol Nurs. 2011;31(5):279-84, 99.12.Holland MA, Joyce JS, Brennaman LM, Drobnis EZ, Starr JA, Foster RT, Sr. Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2019;25(1):76-81.13.Larish AM, Dickson RR, Kudgus RA, McGovern RM, Reid JM, Hooten WM, et al. Vaginal Diazepam for Nonrelaxing Pelvic Floor Dysfunction: The Pharmacokinetic Profile. J Sex Med. 2019;16(6):763-6. ................
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