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

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ClinicalTrials.gov Identifier: NCT00337792
Recruitment Status : Terminated (DSMB review at 50% recruitment, further recruitment unlikely to change result)
First Posted : June 16, 2006
Last Update Posted : March 18, 2016
Sponsor:
Information provided by:
Planned Parenthood League of Massachusetts

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.

Condition or disease Intervention/treatment Phase
Undesired Pregnancy Drug: oxycodone + lorazepam versus fentanyl + midazolam Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
Study Start Date : June 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Pain scale

Secondary Outcome Measures :
  1. Measures of satisfaction, side effects, recovery time


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337792


Locations
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Investigators
Principal Investigator: Jane Doe Planned Parenthood League of Massachusetts

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jane Doe, Planned Parenthood League of MA
ClinicalTrials.gov Identifier: NCT00337792     History of Changes
Other Study ID Numbers: 2005-P-002284/1
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Fentanyl
Oxycodone
Midazolam
Lorazepam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents