IUD Insertion Pain
Conditions
Keywords
IUD, Intrauterine Device, Ketorolac, IUD pain, NSAID, Non-steroidal Anti-Inflammatory Drug, VAS, PASS
Brief summary
To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure.
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.
Interventions
DRUGKetorolac
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.
DRUGPlacebo
Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Able to consent * Desires IUD insertion
Exclusion criteria
* 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 * Contraindications to ketorolac * Current: weight under 50 kilograms * Lifetime history: allergy to NSAIDs, liver disease, renal disease, peptic ulcer disease, cerebrovascular bleeding, gastrointestinal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion, controlling for parity | 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 | 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. |
| Difference in rate of "severe pain" (VAS pain scores 70-100mm) between study arms at 7 timepoints during and after IUD insertion | 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 | 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. |
| Difference in rate of change of VAS pain scores between study arms at 7 timepoints during and after IUD insertion | 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 | 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. |
| Difference in rate of acceptable pain levels between study arms at 7 timepoints during and after IUD insertion | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy G Bryant, M.D.
University of North Carolina, Chapel Hill
Outcome results
None listed