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Sponsors and Collaborators: |
Planned Parenthood League of Massachusetts An anonymous Foundation. |
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Information provided by: | Planned Parenthood League of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00337792 |
The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.
Condition | Intervention |
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Undesired Pregnancy |
Drug: oxycodone + lorazepam versus fentanyl + midazolam |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion |
Enrollment: | 132 |
Study Start Date: | June 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Planned Parenthood League of Massachusetts | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Alisa B Goldberg, MD, MPH | Brigham and Women's Hospital and Planned Parenthood League of Massachusetts |
Responsible Party: | Planned Parenthood League of MA ( Alisa B. Goldberg, MD, MPH/Director of Clinical Research and Training ) |
Study ID Numbers: | 2005-P-002284/1 |
Study First Received: | June 15, 2006 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00337792 |
Health Authority: | United States: Institutional Review Board |
Lorazepam Fentanyl Oxycodone Pain Midazolam |