OPIOID Study - Pain With Osmotic Dilators

Albany Medical College

Status: Completed

Conditions: Abortion in Second Trimester

Treatments: Device: Dilapan-S; Device: Laminaria

Study type: Interventional

Funder types: Other

Identifiers

NCT03710239

5209

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Dilapan-S

Active Comparator group

Description:

Synthetic osmotic dilator

Treatment:

Device: Dilapan-S

Laminaria

Active Comparator group

Description:

Seaweed-based osmotic dilator

Treatment:

Device: Laminaria