Trials / Completed
CompletedNCT03710239
OPIOID Study - Pain With Osmotic Dilators
OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Albany Medical College · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dilapan-S | Synthetic osmotic dilator |
| DEVICE | Laminaria | Seaweed-based osmotic dilator |
Timeline
- Start date
- 2018-10-02
- Primary completion
- 2020-03-11
- Completion
- 2020-03-11
- First posted
- 2018-10-18
- Last updated
- 2020-03-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03710239. Inclusion in this directory is not an endorsement.