Abortion, Dilation and Evacuation, Pain Management, Second Trimester Abortion
Conditions
Keywords
randomized controlled trial, osmotic dilators, ketorolac, paracervical block
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetorolac
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.
DRUGoral ibuprofen
Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.
DRUGPlacebo
Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.
DRUGLidocaine HCl 1%
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.
DRUGSaline
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.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age \>/= 18 years English or Spanish speaking Ability and willingness to sign the informed consent 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 Contraindications 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain post-osmotic dilator insertion | After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal | i. Mean difference between arms in NRS immediately after insertion of osmotic dilators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain with maintenance of osmotic dilators | 5 minutes to 6 hours after insertion 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. |
| Patient Satisfaction | 5 minutes after insertion of osmotic dilators | Mean difference in satisfaction measured with 100mm VAS. |
| Cervical dilators (exploratory) | Intraoperatively at start of D&E | Cervical dilation assessed with digital exam after removal of osmotic dilators at time of D\&E; mechanical dilation performed during D\&E (yes/no) |
Countries
United States
Contacts
CONTACTCristina MA Barkowski, MSW, DrPH(s)
PRINCIPAL_INVESTIGATORSadia MA Haider, MD, MPH
Rush University Medical Center
PRINCIPAL_INVESTIGATORKathryn Crofton, MD
Rush University Medical Center
Outcome results
None listed