A Phase 2 interventional study of Ketorolac and oral ibuprofen in Pain Management, Abortion and Second Trimester Abortion, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure.
The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure. Osmotic dilators are sticks that are inserted into the cervix. They soak up fluid and expand overnight, gently opening the cervix. We are studying an injection of ketorolac (a liquid anti-inflammatory medication similar to ibuprofen) combined with lidocaine (a liquid numbing medication), which is injected vaginally to the area surrounding the cervix. Ketorolac is approved by the U.S. Food and Drug Administration (FDA) for intravenous (IV) and intramuscular injection and has been studied as a paracervical injection for participants having first trimester abortion procedures in the office. It has not previously been studied for osmotic dilator insertion.
120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.
This study's planned enrollment of 76 is close to the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.
Browse Dilatation, Pathologic studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
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Age >/= 18 years English or Spanish speaking Ability and willingness to sign the Ability and willingness to comply with the terms of the study including possessing active cell phone with text messaging capabilities Voluntary request for pregnancy termination Ultrasound-confirmed intrauterine pregnancy with an estimated gestational age of 16+0-23+6 weeks gestational age Require osmotic dilator placement one day prior to procedural abortion according to institutional protocol Seeking outpatient abortion services at Rush University Medical Center
Exclusion criteria:
Have taken NSAIDs less than 6 hours prior to their clinic visit to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria Allergic reaction or sensitivity to NSAIDs History of peptic ulcer or gastrointestinal bleed, history of gastric bypass (RYGB) or recent history in last 6 months of gastric sleeve; history of inflammatory bowel disease (Ulcerative colitis, Crohn's disease) Uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease Acute renal failure or chronic renal disease Chronic liver disease History of bleeding diathesis Untreated acute cervicitis or pelvic inflammatory disease Require or request PO benzodiazepine or IV sedation for placement of osmotic dilators Require more than 1 day of osmotic dilators Chronic or current narcotic use Current recreational drug use (excluding cannabis) Require transabdominal/transvaginal injection for induced fetal demise prior to abortion
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac
Drug: Ketorolac · Drug: Placebo · Drug: Lidocaine HCl 1%
Oral ibuprofen with plain 1% lidocaine paracervical block
Drug: oral ibuprofen · Drug: Lidocaine HCl 1% · Drug: Saline
Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement. Immediately prior to placement of osmotic dilators, a 1% lidocaine + ketorolac paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL ketorolac (30mg) will be administered.
Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.
Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.
Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed in the following fashion: Two milliliters of the analgesic mixture will be placed at the tenaculum site intracervically. After the tenaculum is placed, the remaining 18 mL of the analgesic mixture will be administered at 4 and 8 o'clock at the cervicovaginal reflection.
Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed.
Pain post-osmotic dilator insertion
i. Mean difference between arms in NRS immediately after insertion of osmotic dilators
Time frame: After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal
Pain with maintenance of osmotic dilators
Mean difference between arms in NRS at 5 minutes (in clinic), 30 minutes and 1, 2, 4, 6 hours (all by text-message) after insertion of osmotic dilators.
Time frame: 5 minutes to 6 hours after insertion of osmotic dilators
Patient Satisfaction
Mean difference in satisfaction measured with 100mm VAS.
Time frame: 5 minutes after insertion of osmotic dilators
Cervical dilators (exploratory)
Cervical dilation assessed with digital exam after removal of osmotic dilators at time of D\&E; mechanical dilation performed during D\&E (yes/no)
Time frame: Intraoperatively at start of D&E
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 10 months after the start.
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Studies of the drug tested here: Ketorolac
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