Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)
Information source: Planned Parenthood League of Massachusetts
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Undesired Pregnancy
Intervention: oxycodone + lorazepam versus fentanyl + midazolam (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Planned Parenthood League of Massachusetts Official(s) and/or principal investigator(s):
Alisa B Goldberg, MD, MPH, Principal Investigator, Affiliation: Brigham and Women's Hospital and Planned Parenthood League of Massachusetts
Summary
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.
Clinical Details
Official title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: Pain scale
Secondary outcome: Measures of satisfaction, side effects, recovery time
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age 18 or older.
- Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
- Has already signed consent for pregnancy termination.
- Eligible for IV sedation per clinic protocol.
Exclusion Criteria:
- Under 120 lbs.
- Allergies to any of the drugs being studied.
- Chronic narcotics, barbiturates or benzodiazepine use within the past year.
- History of IV drug use within the last year.
- Inability to give informed consent.
- Does not speak English or Spanish and does not have translator for all study
procedures
- Previously participated in study
Locations and Contacts
Planned Parenthood League of Massachusetts, Boston, Massachusetts 02215, United States
Additional Information
Starting date: June 2006
Ending date: July 2007
Last updated: December 20, 2007
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