Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)

A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00337792

Enrollment

132

Registered

2006-06-16

Start date

2006-06-30

Completion date

2007-07-31

Last updated

2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undesired Pregnancy

Brief 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.

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.

Interventions

DRUGoxycodone + lorazepam versus fentanyl + midazolam

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pain scale	—

Secondary

Measure	Time frame
Measures of satisfaction, side effects, recovery time	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026