OPIOID Study - Pain With Osmotic Dilators

Abortion in Second Trimester Clinical Trial

— OPIOID  

Official title:

OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710239
• Other study ID #: 5209
• Status: Completed
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.

Description:

This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D&E) procedures. Pain levels and medication usage will also be assessed following the D&E procedure itself, up to 7 days after the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled D&E for 15+0 to 23+6 wga

• ability to speak and read in English

• ownership of smartphone with internet access and data plan

Exclusion Criteria:

• chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics

Related Conditions & MeSH terms

• Abortion in Second Trimester

Intervention

Device:
• Dilapan-S
Synthetic osmotic dilator
• Laminaria
Seaweed-based osmotic dilator

Locations

Country	Name	City	State
United States	Albany Medical Center Obstetrics and Gynecology	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain above baseline following Laminaria versus Dilapan-S placement	Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement	First 24 hours after dilator placement
Primary	Time of maximum pain above baseline following Laminaria versus Dilapan-S placement	Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement	First 24 hours after dilator placement
Secondary	Pain medication use after Laminaria versus Dilapan-S placement	Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement	First 24 hours after dilator placement
Secondary	Maximum pain increase over baseline following D&E procedure	Timed surveys measuring pain on Numeric Rating Scale (0-10), administered at 1 hour, 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure	First week after D&E
Secondary	Pain medication use after D&E	Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure	First week after D&E