IUD Insertion PainPhase 2NCT06853327

Oral Ketorolac for IUD Pain Reduction

A Phase 2 study testing Ketorolac in people with IUD Insertion Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: IUD Insertion Pain
What is being tested?: Ketorolac
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 1 siteUnited States
Study dates: 23 May 2025to 30 Aug 2027
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years or older
Able to consent
Desires IUD insertion

Who cannot join

IUD placement under sedation or oral anxiolytic
IUD replacement (removal with insertion)
Daily narcotic or NSAID use
Contraindications to IUD placement
Current: pregnancy, genital/pelvic infection
Lifetime history: uterine anomaly, pelvic inflammatory disease, allergy to levonorgestrel or copper

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Contraindications to ketorolac
Current: weight under 50 kilograms
Lifetime history: allergy to NSAIDs, liver disease, renal disease, peptic ulcer disease, cerebrovascular bleeding, gastrointestinal bleeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

University of North Carolina - Hillsborough Campus
Hillsborough, North Carolina, 27278

Other trials in United States

About this study

Official title: Timing of Oral Ketorolac for Pain Reduction in IUD Insertion: A Double-Blind Randomized Controlled Trial

To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure.

Read the detailed description

This is a single-site prospective interventional randomized controlled trial to examine the timing of administration of ketorolac for IUD pain control. 108 patients will be recruited to the study and they will be randomized into three study arms in a 1:1:1 ratio. Information including demographics, medical history, and obstetric history will be collected during enrollment. Patients will arrive 3 hours prior to their IUD appointment. Study group "K2" will receive ketorolac 20mg per os (PO) at 2 hours prior to IUD insertion, then they will receive a placebo pill at 1 hour prior to IUD insertion. In contrast, study group "K1" will receive the inverse: they will be given a placebo pill at 2 hours prior to IUD insertion, then they will receive ketorolac 20mg PO at 1 hour prior to IUD insertion. Study group "K0" will receive placebo pills at both timepoints. The patients will then receive a standard IUD insertion by an OBGYN physician. Both patients and providers will be blinded to the study medications received. The standard pain control regimen for IUD insertion includes offering vaginal lidocaine gel self-administered 5 minutes prior to IUD insertion as well as offering lidocaine paracervical block (PCB). All patients will be offered these standard pain control methods including the "K0" group. Patients may utilize one, both, or neither of these offered interventions in addition to the randomized study medication. During the IUD insertion, pain scores at 7 different timepoints will be measured via a visual analog scale (VAS). The VAS is a 100mm visual tool that allows patients to rate the pain they are experiencing at each time interval. The 7 timepoints include: pre-procedure, tenaculum placement, block injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure. Information on Patient Acceptable Symptom State (PASS) and patient satisfaction will be collected during their appointment. After the 10-minute post-procedure VAS score and questionnaire, patients will be discharged from the study.

Conditions: IUD Insertion Pain
Being tested: Ketorolac, Placebo
Keywords: IUD, Intrauterine Device, Ketorolac, IUD pain, NSAID, Non-steroidal Anti-Inflammatory Drug, VAS, PASS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetorolacDrug
Also called Toradol
The experimental condition to be examined by this study is the timing of administration of ketorolac prior to IUD insertion. Ketorolac 20mg PO has proven beneficial at certain timepoints during IUD insertion in prior studies, but pharmacokinetics indicate that it could require more time until peak analgesia.
PlaceboDrug
Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens

Study groups in NCT06853327
Study group	Role	What they receive
K2 - Ketorolac 2-hour	Active comparator	Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD Receives: Drug: Ketorolac; Drug: Placebo
K1 - Ketorolac 1-hour	Active comparator	Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD Receives: Drug: Ketorolac; Drug: Placebo
K0 - Placebo control	Placebo comparator	Receives placebo at 2 hours and at 1 hour prior to IUD Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion
To compare the mean VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The VAS scores will be reported as means and compared via repeated measure ANOVA test yielding confidence intervals and p-values and to assess for significance.
Measured: All VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards

Secondary outcomes (4)

Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion, controlling for parity
To compare the mean VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure) with respect to parity. To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. This will determine if nulliparous patients experienced more pain relief with different timings of ketorolac administration. The VAS scores for nulliparous and multiparous patients will be reported as means and compared via repeated measure ANOVA test with interaction term yielding confidence intervals and p-values to assess for significance.
Measured: Parity is recorded during intake 1 week prior to IUD. VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards
Difference in rate of "severe pain" (VAS pain scores 70-100mm) between study arms at 7 timepoints during and after IUD insertion
To compare the rate of "severe pain" (VAS pain scores 70-100mm) between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The rate of severe pain will be reported as percentage of patients and will be compared via chi-square test yielding confidence intervals and p-values to assess for significance.
Measured: All VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards
Difference in rate of change of VAS pain scores between study arms at 7 timepoints during and after IUD insertion
To compare the rate of change of VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The pain scores will be plotted at the listed 7 timepoints and a generalized estimating equation will be used to assess the change in slope from timepoint to timepoint. The change in slope will be reported as means and compared between study arms via repeated measure ANOVA test yielding confidence intervals and p-values and to assess for significance.
Measured: All VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards
Difference in rate of acceptable pain levels between study arms at 7 timepoints during and after IUD insertion
To compare the rate of acceptable pain levels (Patient Acceptable Symptom State (PASS) binary yes/no variable) between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess PASS, the patient will be asked "Do you consider your current pain level acceptable?" at the listed timepoints. The rate of acceptable pain levels will be reported as percentage of patients and will be compared via chi-square test yielding confidence intervals and p-values to assess for significance.
Measured: All PASS responses will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202530 Aug 2027

First posted28 Feb 2025
Study start23 May 2025
Primary completion30 Aug 2027 (estimated)
Study completion30 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for IUD Insertion PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 108 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06853327
Sponsor's protocol ID: 24-2276
Status last verified: Aug 2026
First submitted: 24 Feb 2025
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. J Obstet Gynaecol Can. 2017 Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014. Epub 2017 Aug 18.
PubMed 28826645
Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.
PubMed 26241253
de Oliveira ECF, Baeta T, Brant APC, Silva-Filho A, Rocha ALL. Use of naproxen versus intracervical block for pain control during the 52-mg levonorgestrel-releasing intrauterine system insertion in young women: a multivariate analysis of a randomized controlled trial. BMC Womens Health. 2021 Oct 29;21(1):377. doi: 10.1186/s12905-021-01521-z.
PubMed 34715839
Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746.
PubMed 27824753
Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015 Mar;91(3):193-7. doi: 10.1016/j.contraception.2014.11.012. Epub 2014 Nov 25.
PubMed 25487172
Reeves JA, Zapata LB, Curtis KM, Whiteman MK. Intrauterine Device Training, Attitudes, and Practices Among U.S. Health Care Providers: Findings from a Nationwide Survey. Womens Health Issues. 2023 Jan-Feb;33(1):45-53. doi: 10.1016/j.whi.2022.08.002. Epub 2022 Sep 16.
PubMed 36123229
Akintomide H, Brima N, Sewell RD, Stephenson JM. Patients' experiences and providers' observations on pain during intrauterine device insertion. Eur J Contracept Reprod Health Care. 2015;20(4):319-26. doi: 10.3109/13625187.2015.1031885. Epub 2015 Apr 10.
PubMed 25857221
Rahman M, King C, Saikaly R, Sosa M, Sibaja K, Tran B, Tran S, Morello P, Yeon Seo S, Yeon Seo Y, Jacobs RJ. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024 Mar 8;16(3):e55785. doi: 10.7759/cureus.55785. eCollection 2024 Mar.
PubMed 38586685