Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)
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ClinicalTrials.gov Identifier: NCT00337792
Recruitment Status :
(DSMB review at 50% recruitment, further recruitment unlikely to change result)
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 or disease
Drug: oxycodone + lorazepam versus fentanyl + midazolam
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents