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Meta-Analysis
. 2015 Jul 29;2015(7):CD007373.
doi: 10.1002/14651858.CD007373.pub3.

Interventions for pain with intrauterine device insertion

Laureen M Lopez  1 , Alissa Bernholc, Yanwu Zeng, Rebecca H Allen, Deborah Bartz, Paul A O'Brien, David Hubacher
Affiliations
Meta-Analysis

Interventions for pain with intrauterine device insertion

Laureen M Lopez et al. Cochrane Database Syst Rev. .

Abstract

Background: Fear of pain during insertion of intrauterine contraception (IUC) is a barrier to use of this method. IUC includes copper-containing intrauterine devices and levonorgestrel-releasing intrauterine systems. Interventions for pain control during IUC insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol.

Objectives: To review randomized controlled trials (RCTs) of interventions for reducing IUC insertion-related pain

Search methods: We searched for trials in CENTRAL, MEDLINE, EMBASE, POPLINE, ClinicalTrials.gov, and ICTRP. The most recent search was 22 June 2015. We examined reference lists of pertinent articles. For the initial review, we wrote to investigators to find other published or unpublished trials.

Selection criteria: We included RCTs that evaluated an intervention for preventing IUC insertion-related pain. The comparison could have been a placebo, no intervention, or another active intervention. The primary outcomes were self-reported pain at tenaculum placement, during IUC insertion, and after IUC insertion (up to six hours).

Data collection and analysis: Two authors extracted data from eligible trials. For dichotomous variables, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. In meta-analysis of trials with different measurement scales, we used the standardized mean difference (SMD).

Main results: We included 33 trials with 5710 participants total; 29 were published from 2010 to 2015. Studies examined lidocaine, misoprostol, NSAIDs, and other interventions. Here we synthesize results from trials with sufficient outcome data and moderate- or high-quality evidence.For lidocaine, meta-analysis showed topical 2% gel had no effect on pain at tenaculum placement (two trials) or on pain during IUC insertion (three trials). Other formulations were effective compared with placebo in individual trials. Mean score for IUC-insertion pain was lower with lidocaine and prilocaine cream (MD -1.96, 95% CI -3.00 to -0.92). Among nulliparous women, topical 4% formulation showed lower scores for IUC-insertion pain assessed within 10 minutes (MD -15.90, 95% CI -22.77 to -9.03) and at 30 minutes later (MD -11.10, 95% CI -19.05 to -3.15). Among parous women, IUC-insertion pain was lower with 10% spray (median 1.00 versus 3.00). Compared with no intervention, pain at tenaculum placement was lower with 1% paracervical block (median 12 versus 28).For misoprostol, meta-analysis showed a higher mean score for IUC insertion compared with placebo (SMD 0.27, 95% CI 0.07 to 0.46; four studies). In meta-analysis, cramping was more likely with misoprostol (OR 2.64, 95% CI 1.46 to 4.76; four studies). A trial with nulliparous women found a higher score for IUC-insertion pain with misoprostol (median 46 versus 34). Pain before leaving the clinic was higher for misoprostol in two trials with nulliparous women (MD 7.60, 95% CI 6.48 to 8.72; medians 35.5 versus 20.5). In one trial with nulliparous women, moderate or severe pain at IUC insertion was less likely with misoprostol (OR 0.30, 95% CI 0.16 to 0.55). In the same trial, the misoprostol group was more likely to rate the experience favorably. Within two trials of misoprostol plus diclofenac, shivering, headache, or abdominal pain were more likely with misoprostol. Participants had no vaginal delivery. One trial showed the misoprostol group less likely to choose or recommend the treatment.Among multiparous women, mean score for IUC-insertion pain was lower for tramadol 50 mg versus naproxen 550 mg (MD -0.63, 95% CI -0.94 to -0.32) and for naproxen versus placebo (MD -1.94, 95% CI -2.35 to -1.53). The naproxen group was less likely than the placebo group to report the insertion experience as unpleasant and not want the medication in the future. An older trial showed repeated doses of naproxen 300 mg led to lower pain scores at one hour (MD -1.04, 95% CI -1.67 to -0.41) and two hours (MD -0.98, 95% CI -1.64 to -0.32) after insertion. Most women were nulliparous and also had lidocaine paracervical block.

Authors' conclusions: Nearly all trials used modern IUC. Most effectiveness evidence was of moderate quality, having come from single trials. Lidocaine 2% gel, misoprostol, and most NSAIDs did not help reduce pain. Some lidocaine formulations, tramadol, and naproxen had some effect on reducing IUC insertion-related pain in specific groups. The ineffective interventions do not need further research.

PubMed Disclaimer

Conflict of interest statement

LM Lopez, A Bernholc, Y Zeng are employed at FHI 360, where Hubacher 2006 was conducted. They were not involved in that trial.

RH Allen has served as a clinical trainer for Merck and as a consultant for Actavis and Bayer. She was an investigator of Allen 2013, an included trial.

D Hubacher has served on Advisory Boards for Bayer HealthCare Pharmaceuticals, Inc., Teva Pharmaceuticals, and OCON Medical. He has received product donation from Bayer HealthCare Pharmaceuticals, Inc., Teva Pharmaceuticals, and Merck Sharp & Dohme Corp. He has received research funding from Bayer HealthCare Pharmaceuticals, Inc. and Duramed. He was an investigator of Hubacher 2006, an included trial.

D Bartz and PA O'Brien have no known conflicts of interest.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about risk of bias as percentages across all 33 included studies
3
3
Risk of bias summary: review authors' judgements about risk of bias for each included study
1.1
1.1. Analysis
Comparison 1 Naproxen 300 mg (x 4 doses) + paracervical block versus placebo plus paracervical block, Outcome 1 Mean pain scores during and immediately after IUD insertion.
1.2
1.2. Analysis
Comparison 1 Naproxen 300 mg (x 4 doses) + paracervical block versus placebo plus paracervical block, Outcome 2 Mean pain scores after IUD insertion.
2.1
2.1. Analysis
Comparison 2 Naproxen 550 mg versus placebo, Outcome 1 Mean pain score during IUD insertion.
2.2
2.2. Analysis
Comparison 2 Naproxen 550 mg versus placebo, Outcome 2 Satisfaction or acceptability.
4.2
4.2. Analysis
Comparison 4 Ibuprofen 600 mg versus placebo, Outcome 2 Reported moderate to severe pain during IUD insertion (3 or greater on the 1 to 10 scale).
5.1
5.1. Analysis
Comparison 5 Ibuprofen 800 mg versus placebo, Outcome 1 Mean pain score at tenaculum placement.
5.2
5.2. Analysis
Comparison 5 Ibuprofen 800 mg versus placebo, Outcome 2 Mean pain score at IUD insertion.
7.1
7.1. Analysis
Comparison 7 Lidocaine 2% versus placebo, Outcome 1 Mean pain score at tenaculum placement.
7.2
7.2. Analysis
Comparison 7 Lidocaine 2% versus placebo, Outcome 2 Mean pain score during IUD insertion.
8.1
8.1. Analysis
Comparison 8 Lidocaine 2% gel 6 mL versus placebo, Outcome 1 Mean pain score 20 minutes post‐insertion.
8.2
8.2. Analysis
Comparison 8 Lidocaine 2% gel 6 mL versus placebo, Outcome 2 Side effects or adverse events.
8.3
8.3. Analysis
Comparison 8 Lidocaine 2% gel 6 mL versus placebo, Outcome 3 Satisfaction or acceptability.
9.1
9.1. Analysis
Comparison 9 Lidocaine 2% gel versus no intervention, Outcome 1 Mean pain score during IUD insertion.
11.1
11.1. Analysis
Comparison 11 Lidocaine 4% gel 8.5 mL versus placebo, Outcome 1 Mean pain score for IUD insertion (within 10 min of insertion.
11.2
11.2. Analysis
Comparison 11 Lidocaine 4% gel 8.5 mL versus placebo, Outcome 2 Mean pain score 30 min post‐insertion.
11.3
11.3. Analysis
Comparison 11 Lidocaine 4% gel 8.5 mL versus placebo, Outcome 3 Mean pain score 1 h post‐insertion.
11.4
11.4. Analysis
Comparison 11 Lidocaine 4% gel 8.5 mL versus placebo, Outcome 4 Additional analgesic at clinic.
11.5
11.5. Analysis
Comparison 11 Lidocaine 4% gel 8.5 mL versus placebo, Outcome 5 Side effects or adverse events.
12.1
12.1. Analysis
Comparison 12 EMLA cream 5% (25 mg lidocaine + 25 mg prilocaine) versus placebo, Outcome 1 Mean pain score for tenaculum use.
12.2
12.2. Analysis
Comparison 12 EMLA cream 5% (25 mg lidocaine + 25 mg prilocaine) versus placebo, Outcome 2 Mean pain score immediately after IUD insertion and tube removal.
13.1
13.1. Analysis
Comparison 13 Lidocaine 2% 1.2 mL versus placebo, Outcome 1 Mean pain score at tenaculum placement.
13.2
13.2. Analysis
Comparison 13 Lidocaine 2% 1.2 mL versus placebo, Outcome 2 Mean pain score with IUD insertion.
13.3
13.3. Analysis
Comparison 13 Lidocaine 2% 1.2 mL versus placebo, Outcome 3 Mean global pain score at end of visit.
15.2
15.2. Analysis
Comparison 15 Lidocaine 1% 10 mL paracervical block versus no paracervical block, Outcome 2 Side effects or adverse events.
16.1
16.1. Analysis
Comparison 16 Lidocaine 2% 1.8 mL injected versus ibuprofen 400 mg, Outcome 1 Mean pain scores after IUD insertion.
16.2
16.2. Analysis
Comparison 16 Lidocaine 2% 1.8 mL injected versus ibuprofen 400 mg, Outcome 2 Moderate or severe pain (from VAS).
16.3
16.3. Analysis
Comparison 16 Lidocaine 2% 1.8 mL injected versus ibuprofen 400 mg, Outcome 3 Satisfaction or acceptability.
17.2
17.2. Analysis
Comparison 17 Misoprostol 400 µg + diclofenac 100 mg versus diclofenac 100 mg alone, Outcome 2 Side effects or adverse events.
17.3
17.3. Analysis
Comparison 17 Misoprostol 400 µg + diclofenac 100 mg versus diclofenac 100 mg alone, Outcome 3 Satisfaction or acceptability.
18.1
18.1. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 1 Mean pain score with tenaculum placement.
18.2
18.2. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 2 Mean pain score during IUD insertion.
18.3
18.3. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 3 Mean pain score during IUD insertion by parity.
18.4
18.4. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 4 Mean pain scores post IUD insertion.
18.6
18.6. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 6 Moderate to severe pain (removal of first IUC and insertion of LNG‐IUS.
18.7
18.7. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 7 Moderate to severe pain at IUD insertion.
18.8
18.8. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 8 Side effects or adverse events.
18.9
18.9. Analysis
Comparison 18 Misoprostol 400 μg versus placebo, Outcome 9 Satisfaction or acceptability.
19.1
19.1. Analysis
Comparison 19 Nitric oxide donors versus placebo, Outcome 1 Mean pain score at tenaculum placement.
19.2
19.2. Analysis
Comparison 19 Nitric oxide donors versus placebo, Outcome 2 Mean pain score during IUD insertion.
19.3
19.3. Analysis
Comparison 19 Nitric oxide donors versus placebo, Outcome 3 Mean pain score 30 minutes post IUD insertion.
19.4
19.4. Analysis
Comparison 19 Nitric oxide donors versus placebo, Outcome 4 Satisfaction.
20.1
20.1. Analysis
Comparison 20 Tramadol 50 mg versus naproxen 550 mg, Outcome 1 Mean pain score during IUD insertion.
20.2
20.2. Analysis
Comparison 20 Tramadol 50 mg versus naproxen 550 mg, Outcome 2 Satisfaction or acceptability.
21.1
21.1. Analysis
Comparison 21 Lavender scent versus placebo, Outcome 1 Participants reporting medium or severe pain with IUD insertion.
22.1
22.1. Analysis
Comparison 22 Emptying of bladder: delayed versus immediate, Outcome 1 Mean pain score during IUD insertion.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Ahmadi Doulabi 2013 {published data only}
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Allen 2013 {published data only}
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Bednarek 2013 {published data only}
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Bednarek 2015 {published data only}
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Cameron 2013 {published data only}
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Castro 2014 {published data only}
    1. Castro TV, Franceschini SA, Poli‐Neto O, Ferriani RA, Silva de Sa MF, Vieira CS. Effect of intracervical anesthesia on pain associated with the insertion of the levonorgestrel‐releasing intrauterine system in women without previous vaginal delivery: a RCT. Human Reproduction 2014;29(11):2439‐45. - PubMed
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Chor 2012 {published data only}
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Cırık 2013 {published data only}
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Dijkhuizen 2011 {published and unpublished data}
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Edelman 2011 {published data only}
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Espey 2014 {published data only}
    1. Espey E, Leeman L, Greene H, Singh R, Ogburn T, Fowler K. Misoprostol for IUD insertion in nulliparous women: A randomized controlled trial (abstract). Contraception 2013;88(3):456‐7. - PubMed
    1. Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: A randomized controlled trial. American Journal of Obstetrics and Gynecology 2014;210(3):208.e1‐5. - PubMed
Heikinheimo 2010 {published data only}
    1. Gemzell‐Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel‐releasing intrauterine system (LNG‐IUS)‐‐a multicentre prospective study. Human Reproduction 2010;25(2):354‐9. - PubMed
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Hubacher 2006 {published data only}
    1. Hubacher D, Reyes V, Lillo S, Zepeda A, Chen P, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. American Journal of Obstetrics and Gynecology 2006;195(5):1272‐7. - PubMed
Ibrahim 2013 {published data only}
    1. Ibrahim ZM, Sayed Ahmed WA. Sublingual misoprostol prior to insertion of a T380A intrauterine device in women with no previous vaginal delivery. European Journal of Contraception and Reproductive Health Care 2013;18(4):300‐8. - PubMed
Jensen 1998 {published and unpublished data}
    1. Jensen HH, Blaabjerg J, Lyndrup J. Prophylactic use of prostaglandin synthesis inhibitors in connection with IUD insertion. Ugeskrift for Laeger 1998;160(48):6958‐61. - PubMed
Karabayirli 2012 {published data only}
    1. Karabayirli S, Ayrim AA, Muslu B. Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion. Journal of Minimally Invasive Gynecology 2012;19(5):581‐4. - PubMed
Lathrop 2013 {published data only}
    1. Lathrop E, Haddad L, McWhorter CP, Goedken P. Self‐administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception 2013;88(6):725‐9. - PubMed
Lotke 2013 {published data only}
    1. Lotke P. Use of misoprostol for intrauterine device (IUD) insertion in nulliparous women. clinicaltrials.gov/show/NCT01001897 (accessed 28 October 2014).
    1. Lotke PS, Tiwari A, Nuño VL. Inserting intrauterine devices in nulliparous women: is misoprostol beneficial? A registered clinical trial. American Journal of Clinical and Experimental Obstetrics Gynecology 2013;1(1):62‐8.
Maguire 2012 {published data only}
    1. Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception 2012;86(3):214‐9. - PubMed
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Massey 1974 {published data only}
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McNicholas 2012 {published data only}
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Micks 2014 {published data only}
    1. Micks EA, Jensen JT, Bednarek PH. The effect of nitroglycerin on the IUD insertion experience in nulliparous women: a pilot study. Contraception 2014;90(1):60‐5. - PubMed
Mody 2012 {published data only}
    1. Krishnan S, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: A randomized trial of 1% lidocaine paracervical block (abstract). Contraception 2011;84(3):319. - PubMed
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Mohammad‐Alizadeh‐C 2010 {published data only}
    1. Mohammad‐Alizadeh‐Charandabi S, Seidi S, Kazemi F. Effect of lidocaine gel on pain from copper IUD insertion: a randomized double‐blind controlled trial. Indian Journal of Medical Sciences 2010;64(8):349‐55. - PubMed
Nelson 2013 {published data only}
    1. Nelson AL, Fong JK. Intrauterine infusion of lidocaine does not reduce pain scores during IUD insertion. Contraception 2013;88(1):37‐40. - PubMed
Ngo 2014 {published data only}
    1. Mody S. Pain control for intrauterine device placement: a Ttial of ketorolac prior to intrauterine device placement. clinicaltrials.gov/show/NCT01664559 (accessed 11 September 2014). [NCT01664559]
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Rapkin 2014 {published and unpublished data}
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Sääv 2007 {published data only}
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Scavuzzi 2013 {published data only}
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Shahnazi 2012 {published data only}
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Swenson 2012 {published data only}
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Tornblom‐Paulander 2015 {published and unpublished data}
    1. Pharmanest AB 2013. A randomized, double blind, placebo controlled, parallel group clinical study investigating the analgesic effect and safety of a topical formulation of lidocaine (SHACT) during and after insertion of an Intra Uterine Device. A phase II study. www.clinicaltrialsregister.eu/ctr‐search/trial/2011‐006220‐20/SE (accessed 22 January 2015).
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References to studies excluded from this review

Goldstuck 1983 {published data only}
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Hepburn 1980 {published data only}
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Hollingworth 1995 {published data only}
    1. Hollingworth B. Pain control during insertion of intrauterine device. British Journal of Family Planning 1995;21(3):102‐3.
Jafari 2014 {published data only}
    1. Jafari A, Sayyahi M, Torkashvand R, Piryaei H. Effect of vitamin B1 on pain after insertion of intrauterine device [article in Persian]. Journal of Babol University of Medical Sciences 2014;16(3):13‐20.
Mirmohamad Aliei 2013 {published data only}
    1. Mirmohamad Aliei M, Khazaie F, Rahnama P, Rahimikian F, Modarres M, Bekhradi R, et al. Effect of lavender on pain during insertion of intrauterine device: A clinical trial [article in Persian]. Journal of Babol University of Medical Sciences 2013;15(4):93‐9.
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Oloto 1997 {published data only}
    1. Oloto EJ, Bromham DR, Murty JA. Pain and discomfort perception at IUD insertion‐‐effect of short‐duration, low‐volume, intracervical application of two percent lignocaine gel (Instillagel™)‐‐a preliminary study. British Journal of Family Planning 1997;22(4):177‐80.
Stephenson 2010 {published data only}
    1. Stephenson J. Does topical anaesthetic gel reduce pain/discomfort during intrauterine device (IUD)/intrauterine system (IUD) insertion? A randomised, placebo‐controlled, double‐blind trial. www.controlled‐trials.com/ISRCTN83819888 (accessed 23 September 2014).
Teal 2012 {published data only}
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Thiery 1985 {published data only}
    1. Thiery M. Pain relief at insertion and removal of an IUD: a simplified technique for paracervical block. Advances in Contraception 1985;1(2):167‐70. - PubMed

References to studies awaiting assessment

Brody 2011 {published data only}
    1. Brody K. Topical Lidocaine on the Cervix and Intra‐Cervical Prior to Insertion of Intrauterine Devices (10‐053). http://clinicaltrials.gov/show/NCT01192490 (accessed 17 September 2014).
Elsafty 2011 {published data only}
    1. Elsafty ASE. Efficacy study of topical application of lidocaine spray prior to IUD insertion. clinicaltrials.gov/show/NCT01496105 (accessed 18 September 2014).
Khodokarami 2011 {published data only}
    1. Khodokarami N. The effect of chamomile essential oil on pain intensity of IUD insertion. www.irct.ir/searchresult.php?id=8950&number=1 (accessed 23 September 2014).
Singh 2015 {published data only}
    1. Singh R. Nitrous oxide for pain management of IUD insertion (NIUD). clinicaltrials.gov/ct2/show/NCT02391714 (accessed 4 May 2015). [DOI: ]
    1. Singh RH, Thaxton LD, Carr S, Leeman LM, Schneider E, Espey E. Nitrous oxide for intrauterine device insertion in nulliparous women: a randomized controlled trial [22]. Obstetrics and Gynecology 2015;125(Suppl 1):7S. - PubMed

References to ongoing studies

Fouda 2015 {published data only}
    1. Fouda UM. Diclofenac plus lidocaine gel for pain relief during intrauterine device insertion (IUD). clinicaltrials.gov/show/NCT02332057 (accessed 27 January 2015).
Jamshidi 2014 {published data only}
    1. Jamshidi R. Study of local anesthesia as a method to decrease IUD insertion related pain. clinicaltrials.gov/show/NCT01967017 (accessed 11 September 2013).
Mody 2014 {published data only}
    1. Mody S, Culwell K. Pain control for intrauterine device placement using paracervical block. clinicaltrials.gov/show/NCT02219308 (accessed 11 September 2014).

Additional references

Allen 2014
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