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Completed

NCT Number: NCT03710239

OPIOID Study - Pain With Osmotic Dilators

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

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Key information

Conditions

Abortion in Second Trimester

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center Obstetrics and Gynecology

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dilapan-S

Device

Synthetic osmotic dilator

laminaria

Device

Seaweed-based osmotic dilator

Primary outcomes

  1. Maximum pain above baseline following Laminaria versus Dilapan-S placement

    Time frame: First 24 hours after dilator placement

    Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement

  2. Time of maximum pain above baseline following Laminaria versus Dilapan-S placement

    Time frame: First 24 hours after dilator placement

    Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement

Secondary outcomes

  1. Pain medication use after Laminaria versus Dilapan-S placement

    Time frame: First 24 hours after dilator placement

    Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement

  2. Maximum pain increase over baseline following D&E procedure

    Time frame: First week after D&E

    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

  3. Pain medication use after D&E

    Time frame: First week after D&E

    Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

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

Acronym: OPIOID

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2018
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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