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

Information source: Planned Parenthood League of Massachusetts
ClinicalTrials.gov processed this data on August 23, 2015
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):
Jane Doe, Principal Investigator, Affiliation: 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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
Last updated: April 13, 2009

Page last updated: August 23, 2015

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