Clinical Question: In between two IUD insertion appointments in the clinic during my OB/GYN rotation, I had an interesting conversation with the PA that I was working with. While the standard recommendation for IUD insertion pain management is for patients to take NSAIDs prior to the procedure, I have heard a growing sentiment amongst both clinicians and patients that this practice does not adequately manage IUD insertion pain. The PA I was working with agreed that she didn’t know evidence-based research on the topic, so I decided to do some.
PICO Question: In females undergoing IUD insertion, what is the efficacy of NSAIDs compared to placebo for pain management?
| P | I | C | O |
| Females | NSAIDs | control | Pain control |
| Women | Systemic analgesia | placebo | Pain management |
| Naproxen | Reduced pain | ||
| Ketorolac | Comfort | ||
| Ibuprofen |
Search Strategy:
The search tools and terms used are identified & and are consistent with the CAT. Any relevant limits, filters, etc. are included, with explanation on how the few articles were selected.
- CUNY York OneSearch
- iud insertion analgesia → 2018-2024 → 28 results
- The Samy et al. SR was on the first page of results
- Once on the PubMed link, I clicked “See all Similar Articles”
- I found the Sandoval et al. article on the second page of similar articles generated
- Once on the PubMed link, I clicked “See all Similar Articles”
- The Samy et al. SR was on the first page of results
- Iud insertion NSAIDs → 2020-2024 → newest first → 27 results
- The Rahman et al. study was the first result
- iud insertion analgesia → 2018-2024 → 28 results
- NIH PMC
- “iud insertion analgesia review” → 5 years → 45 results
- None of the articles on the first page seemed to apply, so I did not use any of them and stopped looking
- “iud insertion analgesia review” → 5 years → 45 results
- Google Scholar
- iud pain management systematic review → 2018-2024 → 16,800 results
- I found the Gemzell-Danielsson K et al. article on the first page of results
- iud pain management systematic review → 2018-2024 → 16,800 results
In searching for my articles, my strategy had a few different components. First, I decided to only include articles from the past five years. I felt that this was especially important while researching gynecological medicine because it is an unfortunately controversial topic in our society, and its protocols and perceptions may change more frequently than other areas of medicine. Therefore, I wanted to ensure that my chosen articles were up to date. From there, I knew I wanted to focus primarily on systematic reviews/meta-analyses – Not only because they provide the highest level of evidence, but also because I know that my search question is fairly broad. Being that there are so many types of NSAIDs commonly used in American medicine, I felt that only a systematic review that included qualifying articles that tested a variety of different NSAID agents could be helpful in evaluating the drug class on a larger scale to help answer my research question. RCTs and other types of studies often focus only on one drug, and while it is important for me to know the efficacy of individual drugs while developing the answer to my research question, it felt much more efficient to seek out high power systematic reviews that analyzed multiple RCTs at once. From there, I browsed articles and chose ones that thoroughly vetted the articles they included and specifically had analyses dedicated to the efficacy of NSAIDs. Of note, although the Sandoval et al. study is not a systematic review, its aims were highly relevant to my research question and it reviewed multiple RCTs at once, which aligned with my research strategy.
Articles Chosen for Inclusion:
| Link | Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis |
| Citation | Samy A, Abbas AM, Mahmoud M, et al. Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril. 2019;111(3):553-561.e4. doi:10.1016/j.fertnstert.2018.11.012 |
| Abstract | Objective: To synthesize the evidence on the most effective medications for the relief of intrauterine device (IUD) insertion-related pain.Design: Systematic review and network meta-analysis of randomized controlled trials (RCTs).Setting: Not applicable.Patient(s): Patients undergoing IUD insertion who received different medications for pain relief versus those who received placebo.Intervention(s): Electronic search in the following bibliographic databases: Medline via PubMed, SCOPUS, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and ScienceDirect.Main outcome measure(s): Visual analog scale (VAS) pain score during tenaculum placement, IUD insertion, and 5 to 20 minutes after insertion, the score of easiness of insertion and the need for additional analgesics.Result(s): The present review included 38 RCTs (n = 6,314 patients). The network meta-analysis showed that lidocaine-prilocaine cream (genital mucosal application) statistically significantly reduced pain at tenaculum placement compared with placebo (mean difference -2.38; 95% confidence interval, -4.07 to -0.68). In the ranking probability order, lidocaine-prilocaine cream ranked the highest in reducing the pain at tenaculum placement, followed by lidocaine (paracervical). Similarly, lidocaine-prilocaine cream ranked as the highest treatment in pain reduction during IUD insertion, followed by lidocaine (paracervical).Conclusion(s): Lidocaine-prilocaine cream is the most effective medication that can be used for IUD insertion-related pain. Other medications are not effective. |
| Link | Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. |
| Citation | Rahman M, King C, Saikaly R, et al. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024;16(3):e55785. Published 2024 Mar 8. doi:10.7759/cureus.55785 |
| Abstract | Pain control and anxiety management during intrauterine device (IUD) insertion should be a highly prioritized aspect standard of care during the procedural treatment plan. In fact, pain perceived by females during intrauterine device insertion often limits the use of this effective contraceptive method. However, there is said to be a gap in the literature regarding official procedures for pain management during IUD implantation. This recently published systematic review sought to analyze pain control options during IUD insertion. Regarding pharmacological methods, local agents were significantly more effective in controlling pain than systemic agents including intramuscular naproxen, diclofenac, ketorolac, and prophylactic oral ibuprofen, none of which produced effective pain relief. This suggests that it is important to have a drug act directly in the vagina and on the cervix to manage pain during IUD insertion. Specifically, lidocaine administration via paracervical block appears to be most effective option and should be utilized more frequently by clinicians performing IUD insertion procedures. |
| Link | Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review |
| Citation | Gemzell-Danielsson K, Jensen JT, Monteiro I, et al. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019;98(12):1500-1513. doi:10.1111/aogs.13662 |
| Abstract | A 2013 review found no evidence to support the routine use of pain relief for intrauterine contraceptive (IUC) placement; however, fear of pain with placement continues to be a barrier to use for some women. This narrative review set out to identify (1) new evidence that may support routine use of pain management strategies for IUC placement; (2) procedure‐related approaches that may have a positive impact on the pain experience; and (3) factors that may help healthcare professionals identify women at increased risk of pain with IUC placement. A literature search of the PubMed and Cochrane library databases revealed 550 citations, from which we identified 43 new and pertinent studies for review. Thirteen randomized clinical trials, published since 2012, described reductions in placement‐related pain with administration of oral and local analgesia (oral ketorolac, local analgesia with different lidocaine formulations) and cervical priming when compared with placebo or controls. Four studies suggested that ultrasound guidance, balloon dilation, and a modified placement device may help to minimize the pain experienced with IUC placement. Eight publications suggested that previous cesarean delivery, timing of insertion relative to menstruation, dysmenorrhea, expected pain, baseline anxiety, and size of insertion tube may affect the pain experienced with IUC placement. Oral and local analgesia and cervical priming can be effective in minimizing IUC placement‐related pain when compared with placebo, but routine use remains subject for debate. Predictive factors may help healthcare professionals to identify women at risk of experiencing pain. Targeted use of effective strategies in these women may be a useful approach while research continues in this area. |
| Link | Alleviating Pain with IUD Placement: Recent Studies and Clinical Insight. |
| Citation | Sandoval, S., Meurice, M.E., Pebley, N.B. et al. Alleviating Pain with IUD Placement: Recent Studies and Clinical Insight. Curr Obstet Gynecol Rep 11, 12–20 (2022). https://doi-org.york.ezproxy.cuny.edu/10.1007/s13669-022-00324-9 |
| Abstract | Purpose of ReviewThe pain associated with intrauterine device placement (IUD) may decrease uptake of this highly effective form of contraception. The purpose of this review is to present recently studied methods and techniques employed by clinicians to reduce pain with IUD placement.Recent FindingsParacervical and intracervical lidocaine blocks are effective options for pain control during IUD placement. Lidocaine blocks are particularly effective in nulliparous patients during IUD placement. Topical or vaginal lidocaine are not effective in decreasing pain with IUD placement.SummaryBased on the existing published literature and our clinical experience, we recommend clinicians use several modalities to decrease pain associated with IUD placement. For nulliparous women, we recommend an intracervical or paracervical lidocaine block prior to IUD placement. Misoprostol use should be limited to when a patient had a prior unsuccessful IUD placement attempt or known cervical stenosis. NSAIDs can help with post-procedure pain but do not help with pain during the placement. |
Summary of the Evidence:
| Author (Date) | Level of Evidence | Sample/Setting(# of subjects/ studies, cohort definition etc. ) | Outcome(s) studied | Key Findings | Limitations and Biases |
| Samy et al., 2019 | SR with Meta-analysis | 38 RCTs (n = 6,314 patients)Trials included:1) menstruating nulliparous or multiparous women receiving IUD insertion in the form of LNG or copper-bearing devices, 2) examination of medications for the management of IUD insertion-related pain, 3) comparison of interventions with placebo Exclusion of: head-to-head trials with no placebo arm, studies published in languages other than English, academic theses, and conference proceedings. | -Visual analog scale (VAS) pain score during tenaculum placement, IUD insertion, and 5 to 20 minutes after insertion-Score of easiness of insertion-Need for additional analgesics | NSAIDs were not effective in reducing IUD-insertion related pain, regardless of their type or dose. -20 mg of ketorolac demonstrated a superior trend over other NSAIDs, nitroprusside, nitroglycerine, and misoprostol in reducing insertion-related pain. -Naproxen administered in conjunction with lidocaine paracervical block before IUD insertion may result in a greater reduction in pain | – There were statistically significant inconsistencies in the pooled effect estimates, which may have been due to wide variations in the characteristics of studies’ population, designs, and reference tests- The methodological quality of the included studies ranged from low to moderate, which may have affected the quality of the present evidence. |
| Rahman et al., 2024 | Systematic Review | N = 19 studies- peer-reviewed, published between January 2015 and September 2022, and discussed pain management protocols for IUD insertion- Only randomized controlled trials, cohort studies, and case studies were included – limited to those that included women who were 18-65 years old or of childbearing age who did not have the following: 1) any other comorbidities or medical conditions (PID, adenomyosis, etc.) and 2) any other concurrent contraceptive use. | -Visual analog scale (VAS) pain score during tenaculum placement, IUD insertion, and 5 to 20 minutes after insertion | Systemic methods of analgesia did not produce effective pain relief, meaning it is important to have the drug act directly in the vagina and on the cervix to manage pain during IUD insertion Pain reduced with:-combination of two 50 mg diclofenac potassium oral tablets and 2% lidocaine cervical gel- 20 mg ketorolac oral tablets-Cervical cream (+prilocaine) Pain did not reduce with:-Lidocaine Intrauterine solution ± oral naproxen-Oral Naproxen ± intrauterine lidocaine-IM ketorolac (but had reduced pain 5 and 15 minutes following IUD insertion)-Oral ibuprofen | – Small sample sizes increasing the risk of error-Search criteria failed to include a specific IUD- The perception of pain is inherently individualized and nuanced, rendering it a challenging parameter to accurately quantify and report. -There is little data evaluating the pain experienced in the days following IUD insertion. |
| Gemzell-Danielsson et al., 2019 | Systematic Review | -Studies analyzing pharmacological interventions for pain management during IUD placement, published from December 2012 to September 2018-The final numberof publications included in our review was 43. | -10‐cm or 100‐mm visualanalogue scale (VAS), where 0 is equivalent to “no pain” and 10 isequivalent to “worst pain ever”, by study participants to indicatethe severity of pain experienced at various times during procedure | Reduction of pain with:- oral ketorolac (20 mg) given 40‐60 minutes before IUD placement when compared with placebo, but 1‐2 hours after administration Insignificant reduction of pain:-550 mg naproxen sodium, N2O/O2, and ibuprofen | -The study was not limited to RCTs, so study quality and sample size may vary, increasing the risk of error and decreasing the level of evidence-The perception of pain is subjective and not all studies assessed for it at the same times-There is little data evaluating the pain experienced in the days following IUD insertion |
| Sandoval et al., 2022 | Literature Review | The purpose of this review is to present recently studied methods and techniques employed by clinicians to reduce pain with IUD placement. The article does not explicitly state its selection criteria, however, it reviews and compares the findings of ~30 individual peer-reviewed RCTs testing the efficacy of every clinically relevant category of IUD insertion analgesic interventions. The review itself is peer-reviewed. | -The visual analogue scale (VAS), asking participants to mark their pain intensity from 0 mm (no pain) to 100 mm (worst pain). -Prior studies have established a clinically significant reduction in pain as a reduction of 15–20 mm on the 100 mm VAS | -NSAIDs do not help with pain control at the time of IUD placement, NSAIDs do decrease post-procedural cramping, likely through inhibition of prostaglandin production. -800 mg ibuprofen compared with placebo given thirty to forty-five minutes prior to IUD placement had no effect-30mg of ketorolac IM 30min prior to IUD placement had significant lower pain scores at 5-15 min after IUD placement -550 mg oral naproxen given one hour prior to placement had significant lower pain scores at 5-15 min after IUD placement | -The selection criteria of the included RCTs were not explicitly outlined, so this is more of a literature review than a systematic review and it is possible the quality of the articles compromise the quality of the study–The perception of pain is subjective and not all studies assessed for it at the same times-There is little data evaluating the pain experienced in the days following IUD insertion |
Conclusion(s):
Samy et al found that NSAIDs, including ketorolac, were not effective in reducing IUD-insertion related pain overall. However, 20 mg of ketorolac showed a trend of superiority over other NSAIDs, nitroprusside, nitroglycerine, and misoprostol in reducing insertion-related pain. Additionally, naproxen administered with lidocaine paracervical block before IUD insertion may result in a greater reduction in pain.
Rahman et al found that systemic methods of analgesia were not effective in providing pain relief during IUD insertion. Direct application of analgesics in the vagina and on the cervix showed some effectiveness in reducing pain, particularly with combinations such as diclofenac potassium oral tablets and lidocaine cervical gel, and 20 mg ketorolac oral tablets.
Gemzell-Danielsson et al found that oral ketorolac (20 mg) given 40‐60 minutes before IUD placement was found to reduce pain compared to placebo. However, other interventions like 550 mg naproxen sodium, nitrous oxide/oxygen, and ibuprofen showed insignificant reduction in pain.
Sandoval et al found that interventions such as 800 mg ibuprofen, 30 mg of ketorolac IM, and 550 mg oral naproxen given prior to IUD placement did not show a significant difference in mean or median pain scores during insertion. However, there were some reductions in pain scores noted at specific time points after IUD placement in the ketorolac and naproxen groups.
Systemic methods of analgesia as monotherapy do not appear to provide effective pain relief during IUD insertion. While some studies found oral ketorolac to be an effective modality, findings are inconsistent. However, NSAIDs may be useful in combination with direct application of analgesics in the vaginal and cervical regions during the procedure, as well as an intervention to reduce post-procedural pain, possibly through inhibition of prostaglandin production. Of the NSAIDs commonly used, oral ketorolac seems to show the greatest analgesic effect across studies (although not unequivocally, as Samy et al. did not find it to be effective). Naproxen and diclofenac have mixed results and perhaps a greater benefit as an adjunct, and ibuprofen is consistently ineffective.
Clinical Bottom Line:
In developing my clinical bottom line, it is important to compare and contrast the findings of articles, while acknowledging they each have varying strength as sources. The Samy et al. systematic review, being the most robust study that I evaluated and the only meta-analysis, is of the highest evidence. It provides a comprehensive overview of the efficacy of NSAIDs for pain management during IUD insertion and analyzes multiple NSAIDs to assess their effectiveness and compare effects between studies. However, its robustness may have a negative effect on its strength of evidence as it created more instances of inconsistencies between studies. The Rahman et al. study is the most recent study and is also extremely systematic, so comparing it with Samy et al. is of high value. The Gemzell-Danielsson et al. systematic review is of lesser quality than the two aforementioned, since it was not limited to RCTs. Lastly, since the Sandoval et al. article is not a systematic review, it still aligns with my research strategy of using sources that review multiple studies, and offers additional data to compare and contrast to the higher strategy studies.
Keeping this in mind, I feel as though my clinical bottom line is that NSAIDs alone are not effective in pain management during IUD insertion. My strongest article by Samy et al. definitely concludes this to be the case. Although some studies found 20mg oral ketorolac monotherapy to be effective, most studies analyzed in my sources seem to agree that a clinically significant reduction in pain as a reduction of 15–20 mm on the 100mm VAS, and the statistically significant analgesic effect of ketorolac monotherapy seen in certain studies was not large. This relatively small effect in combination with the ineffective findings of Samy et al. lead me to conclude that ketorolac monotherapy as an analgesic modality during IUD insertion is not effective.
With all of this being said, NSAIDs can and should have an adjunct role in patients undergoing IUD insertion. All studies agree that certain dual therapies combining systemic NSAIDs with topical intracervical analgesic gels/creams are effective analgesic options for IUD insertion. Given that ketorolac seems to show the most consistent and possibly monotherapeutic effect, I would prescribe a dual therapy pain management plan with preprocedural oral ketorolac in combination with an intracervical agent at the time of the procedure. This should reduce pain both during and after the IUD insertion. Naproxen dual therapy is also worthy of consideration, taking into account the individual histories, needs, and preferences of patients, as multiple studies found this regimen effective as well. In the future, it would be helpful to conduct a study comparing a ketorolac/intracervical topical agent dual therapy regimen with a naproxen/intracervical topical agent dual therapy regimen in order to determine with certainty if one is more effective than the other.
