Evidence map›Paper›PMID 26222246›Full record

SynthesisThe Cochrane database of systematic reviews2015

Interventions for pain with intrauterine device insertion.

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

5 registry-linked trialsOpen access · greenAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in The Cochrane database of systematic reviews, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
20.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03362905 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial

TypeinterventionalSponsorAin Shams UniversityRan2017 to 2019Enrolled123ConditionsIUD Insertion ComplicationArmsLidocaine topical
NCT03587077 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Effect of Adding Vaginal Isosorbide Mononitrate to Misoprostol Prior to Intrauterine Device Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Controlled Clinical Trial

TypeinterventionalSponsorAssiut UniversityRan2018 to 2019Enrolled113ConditionsIUD Insertion ComplicationArmsMisoprostol, Placebos, isosorbide mononitrate
NCT04963582 nacompletednot on this mapstarted 2021, after this paper: background citation

Does LI4 Acupuncture Provide an Effective Analgesia During Intrauterine Device

TypeinterventionalSponsorNigde Omer Halisdemir UniversityRan2021 to 2021Enrolled72ConditionsIUD Insertion Complication, Acute PainArmsAcupuncture
NCT07044622 nawithdrawnnot on this mapstarted 2025, after this paper: background citation

Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Pain

TypeinterventionalSponsorYale UniversityRan2025 to 2026Enrolled0ConditionsPainArmsTranscutaneous Electrical Nerve Stimulation (TENS)
NCT07138248 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study

TypeobservationalSponsorAssiut UniversityRan2025 to 2026Enrolled138ConditionsEvaluation of IUD Position Six Weeks After Insertion, Intrauterine Device Placement and DisplacementArms2D Transvaginal Ultrasound
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 226 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Misoprostol for intrauterine device placement.The Cochrane database of systematic reviews · 2025
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Anticipated Pain During Intrauterine Device Insertion.Journal of pediatric and adolescent gynecology · 2020
    Trial
  10. Trial
  11. Trial
  12. Pain at intrauterine device placement in a Brazilian center.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
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  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Laureen M LopezClinical and Epidemiological Sciences, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.
Alissa Bernholc
Yanwu Zeng
Rebecca H Allen
Deborah Bartz
Paul A O'Brien
David Hubacher
Family Health International 360 · USBrigham and Women's Hospital · USCentral London Community Healthcare NHS Trust · GBProvidence College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFear 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.

objectivesTo review randomized controlled trials (RCTs) of interventions for reducing IUC insertion-related pain SEARCH

methodsWe 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

resultsWe 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'

conclusionsNearly 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.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalFemaleHumansIbuprofenIntrauterine DevicesLidocaineMisoprostolNaproxenOxytocicsPainPrilocaineRandomized Controlled Trials as TopicAnti-Inflammatory Agents, Non-SteroidalIbuprofenLidocaineMisoprostolNaproxenOxytocicsPrilocaine

Identifiers

PMID26222246
PMCPMC9580985
OpenAlexW2135191168

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.