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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
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.
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGPain 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.