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Leon Speroff Professor and Vice Chair for Research, Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland
Dr. Jensen reports that he is a consultant for and receives grant/research support from Bayer, Merck, ContraMed, and FHI360; he receives grant/research support from Abbvie, HRA Pharma, Medicines 360, and Conrad; and he is a consultant for the Population Council.
We have turned a corner in contraception use, with long-acting reversible contraceptive (LARC) methods (intrauterine devices [IUDs] and implants) showing an increased proportion of users each year at the expense of permanent and short-acting hormonal methods. The most recent published data from the National Survey of Family Growth revealed that about 90% of women at risk for unintended pregnancy report use of a contraceptive method, and that between 2008 and 2014, the proportion of women using a permanent contraception method decreased 8% while LARC method use increased 8%.1 Although this suggests a shift in use among family completers, implant and IUD use also has soared among younger nulliparous women. In 2014, 4% of young women 15 to 19 years of age and 13% of women 20 to 24 years of age reported use of an IUD. As we can expect to see further increases in use, it makes sense to consider how best to improve the IUD placement experience, particularly for young nulliparous women.
What do we know about management of pain associated with IUD placement? In 2013, Gemzell-Danielsson and colleagues reviewed the literature and concluded that insufficient evidence existed to support the use of any routine prophylactic pharmacological intervention for pain reduction during or after IUD insertion.2 This review highlighted the importance of the clinician’s role in adequate counseling and the creation of a trusting, unhurried clinical encounter to assuage the patient’s potential fear of the procedure. These authors termed this clinical experience “verbal anesthesia.” Let’s examine the basis for this conclusion and whether new literature exists to inform our practice.
Nonsteroidal anti-inflammatory agents (NSAIDs): Since the publication of the Gemzell-Danielsson review, additional investigators have confirmed the 2006 randomized, controlled trial conducted by Hubacher et al, who found no benefit of prophylactic ibuprofen on IUD placement pain in Chilean women.3 But what about American women? Bednarek et al randomized women to receive either ibuprofen 800 mg or placebo 30 to 45 minutes (peak levels occur one to two hours after oral administration) prior to IUD insertion and evaluated pain using a 100 mm visual analogue scale (VAS).4 They found no significant overall difference in median pain scores (42 mm placebo, 38 mm ibuprofen; P = 0.50), and no difference when nulliparous and parous women were analyzed independently. However, median pain scores were clinically and significantly higher in nulliparous women (+18 mm) compared to parous women. Does drug administration timing affect the results? Ngo et al evaluated prophylactic administration of oral naproxen sodium (550 mg) 60 to 90 minutes (peak one hour) prior to IUD placement and found no significant improvement in pain with IUD placement but a significant reduction in post-procedure pain scores five minutes (17 vs. 26 mm; P = 0.01) and 15 minutes (13 vs. 24 mm; P = 0.01) later.5
What about other NSAIDs? Using a double-blind RCT design, Crawford et al administered oral ketorolac 20 mg or placebo 40 to 60 minutes prior to IUD placement and used a numeric rating system (1-10) to evaluate pain. These authors found both a clinically significant improvement in placement (4.2 vs. 5.7; P = 0.031) and post-procedure (10 min; 1.1 vs. 2.5; P = 0.007) pain with active treatment. However, an intramuscular (IM) injection of a higher dose of ketorolac (30 mg) given 30 minutes prior to IUD placement did not confirm the benefit with placement pain (median 5.2 cm vs. 3.6 cm; P = 0.99)
compared to saline injection, but did decrease post-procedure pain at 5 (2.2 cm vs. 0.3 cm; P ≤ 0.001) and 15 (1.6 cm vs. 0.1 cm; P ≤ 0.001) minutes. While a longer wait time might have made a difference with the IM treatment, this would not represent a practical approach for most clinics. Taken together, the evidence seems weak for an overall benefit of NSAIDs on placement pain but encouraging for post-placement pain. It makes sense to stick with oral agents and to provide instructions for patients to self-administer maximum doses of over-the-counter agents such as ibuprofen or naproxen one hour prior to the scheduled procedure to improve their post-procedure experience.
Nitrous oxide: Singh et al randomized 80 women to inhale either oxygen (O2) or a mixture of 50% nitrous oxide and 50% oxygen (N2O/O2) through a nasal mask for two minutes before IUD insertion and used VAS to assess maximum pain experienced two minutes after IUD placement (a time when the N2O was expected to have cleared).6 They found no difference in the post-placement pain scores (54 mm N2O/O2; 55 mm O2) or overall satisfaction (66 mm vs. 63 mm). The absence of a large effect on satisfaction does not support that assessment of pain at the time of placement would have made a difference. However, as clinicians gain more experience with the obstetric use of N2O/O2, I expect we will see additional studies using higher doses (70% N2O/30% O2). The safety and rapid onset/termination of N2O/O2 effects make this an attractive option for clinic use.
Cervical preps: Gemzell-Danielsson et al found no good evidence to support the routine use of misoprostol prior to placement of an IUD and found some evidence of harm, with consistency of effect in most studies examined. Two recently published studies have suggested benefit in women with prior cesarean delivery (CD)7 and in nulliparous women.8 In the post-CD study, the authors reported a clinically and statistically significant reduction in insertion pain (2.2 vs. 4.2; P = 0.0001) and successful placements (99% vs. 87%; P = 0.009) using 800 mcg of vaginal misoprostol three hours prior to the procedure. However, the success of placement in the placebo group seems surprisingly low. Consistent with all studies of misoprostol, treated women experienced a variety of side effects, such as cramping pain (23% vs. 4% placebo) and shivering (14% vs. 3%). In a study of nulliparous women, Scavuzzi et al used a 400 mcg dose of vaginal misoprostol four hours prior to the placement attempt. Although misoprostol treatment did not improve the proportion of successful procedures (95% misoprostol, 97% placebo), fewer women reported moderate/severe pain (37% vs. 67%; P < 0.001), and clinicians rated the insertions procedures less difficult. Again, women treated with misoprostol experienced more cramping pain prior to the procedure, raising questions about routine tolerability and blinding. These new papers do not change my advice against the routine use of misoprostol prior to IUD placement.
However, a final study worth noting is the 2015 paper by Bahamondes and colleagues.9 These authors recruited a group of women with a failed attempt at IUD placement at their institution (104 out of 2,535 attempts; 4%), randomizing 100 to self-insertion of either misoprostol 200 mcg or placebo vaginally 10 and four hours prior to a new insertion attempt. Misoprostol treatment increased the proportion of successful placements (88% vs. 62%). Although the paper lacks details on side effects, the authors reported that only 10% of the misoprostol-treated women experienced abdominal pain or cramping. This paper provides high-quality evidence to support the use of misoprostol in women who have experienced a failed attempt by an experienced clinician. The protocol of self-treatment with a lower dose of misoprostol also seems to reduce side effects and does not interrupt clinic flow.
Paracervical block (PCB): Any benefit from PCB must exceed the cost, inconvenience, and pain of administration. Very limited evidence exists to support the routine use of PCB because of the high level of pain with administration. Recently, Akers and colleagues randomized young (14 to 22 years of age) nulliparous women receiving a small frame 13.5 mg levonorgestrel intrauterine system to a 10 mL 1% lidocaine PCB or sham pressure with a cotton-tip applicator, followed by a three-minute delay prior to placement attempt.10 This group found a statistically and clinically significant reduction in VAS pain scores at all time points associated with the procedure except for the PCB. But the pain scores for block time point also were lower for the active PCB (33 mm) compared to the sham (54 mm), raising concerns about the quality of blinding. This makes these results difficult to interpret, particularly given the great tolerance and high success seen with placement of these small diameter devices in nulliparous women.11
Given that most procedures go very well, the PCB may be an excessive intervention. If we believe the data from Akers et al, it appears that placement of a tenaculum represents the primary intervention that stimulates pain. So what about strategies to manage this?
Cervical analgesia: Several recent studies suggest that providing pre-insertion local anesthesia at the cervix can reduce pain with IUD placement. These results are consistent with the above PCB study. Two RCTs found lidocaine spray superior to lidocaine gel12 and cream or injection.13 However, the magnitude of the improvement was of marginal clinical significance (15 mm), and the difficulty of adequately blinding the intervention raises questions regarding the rigor of both studies. Similar results come from studies of lidocaine and lidocaine/prilocaine (EMLA) gels applied topically or in the cervical canal.14
Nonpharmacologic interventions: Authors of several studies have noted that fear of pain at the time of placement is a barrier to choosing an IUD.3,15 Finding ways to reduce stress and fear should decrease pain and improve the experience. Many women seek alternatives to pharmacologic interventions. Shahnazi and colleagues found that aromatherapy with lavender could reduce pain and anxiety prior to IUD placement attempt, but the effect size was small.16 Ireland and Allen reviewed pain management strategies for office gynecologic procedures, including IUD placement.17 My favorite approach is the use of verbal anesthesia suggested in the Gemzell-Danielsson et al review. I prefer the term “verbacaine.” This low-cost intervention requires some practice, but costs nothing and uses no supplies. Under this paradigm, the clinician creates a setting that allows the encounter to succeed. After an appropriate counseling session for informed consent, the conversation turns to a pleasant distracting chatter to prevent the patient from focusing on the procedure and her potential fears. Rather than unduly stressing or ignoring potential pain, I like to normalize the experience and reinforce a sense of control. Strategies like coughing or singing provide a useful distraction during placement of the tenaculum, but must occur concurrent with placement and not before or after. If the women report no more than moderate discomfort with the tenaculum and require no dilation, we proceed without additional local anesthetic. Uncommonly, tenaculum placement results in more significant discomfort. In this case, I remove the device quickly and provide an appropriate block. In my experience, fewer than one in 10 placements require a local anesthetic. Obviously, clinical experience represents the lowest level of medical evidence, so you should cautiously consider these remarks. However, there are few risks to kindness and no costs.
Are some women at more risk of a painful experience? When you look across studies, several baseline characteristics are associated with higher levels of pain: severe dysmenorrhea, nulliparity, and anxiety. Women who report high levels of pain with prior gynecologic procedures also figure into this high-risk group. Following a standardized practice does not mean doing the same thing for all women. Although I believe that most women do not require additional pharmacologic interventions for IUD placement, some may benefit from pre-procedure NSAIDs and a PCB. Extremely anxious women or those with a history of a failed or extremely painful placement attempt may benefit from sedation. However, most women, including young nulliparous women, will do great with only a supportive, caring clinic encounter.
The practice of medicine is an art and a science. Our evidence-based approach to care provides guidelines for best scientific practice. Unfortunately, with respect to pain-reduction strategies for IUD placement, the clinical benefit of most strategies is marginal at best. More research is needed. Until then, first, do no harm. Be a master clinician and practice the art.
Financial Disclosure: OB/GYN Clinical Alert’s Editor Jeffrey T. Jensen, MD, MPH, reports that he is a consultant for and receives grant/ research support from Bayer, Merck, ContraMed, and FHI360; he receives grant/research support from Abbvie, HRA Pharma, Medicines 360, and Conrad; and he is a consultant for the Population Council. Peer Reviewer Catherine Leclair, MD; Nurse Planners Marci Messerle Forbes, RN, FNP, and Andrea O’Donnell, FNP; Editorial Group Manager Terrey L. Hatcher; Executive Editor Leslie Coplin; and Editor Jonathan Springston report no financial relationships relevant to this field of study.