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Evaluation of Oral Midazolam in First-trimester Surgical Abortions

Primary Purpose

Pain, Anxiety, Nausea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Midazolam
Ibuprofen
Placebo-Cherry syrup
Lidocaine
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, anxiety, surgical abortion, midazolam, benzodiazepine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years or older
  • Voluntarily requesting surgical pregnancy termination
  • Pregnancy with intrauterine gestational sac between 6 0/7 and 10 6/7 weeks gestation, dated by ultrasound
  • Eligible for suction aspiration
  • English or Spanish speaking
  • Good general health
  • Able and willing to give informed consent and agree to terms of the study
  • Have assistance home; no driving for 24 hours

Exclusion Criteria:

  • - Gestational ages 11 0/7 weeks or more
  • Gestational age less than 6 0/7 weeks
  • Incomplete abortion
  • Premedication with misoprostol
  • Use of narcotic pain or anti-anxiety medication within past 24 hours
  • Use of heroin or methadone within last 3 months
  • Chronic alcoholism or alcohol intoxication within past 24 hours
  • Requested narcotics or Intravenous sedation (prior to randomization)
  • Allergic reaction or allergy to cherry/cherry flavoring or lidocaine or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Allergic reaction or sensitivity to benzodiazepines including hyperactive or aggressive behavior (paradoxical reaction)
  • Medical problem necessitating inpatient procedure
  • Untreated acute cervicitis or pelvic inflammatory disease
  • Known acute narrow-angle glaucoma
  • Weighing less than 100 lb (45 kg)
  • Use of potent medications interfering with microsomal metabolism within past 48 hours (carbamazepine (Tegretol), cimetidine (Tagamet), diltiazem (Cardizem), erythromycin, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), nelfinavir, ranitidine (Zantac), rifampin (Rifadin), ritonavir (Norvir), saquinavir, verapamil (Calan))

Sites / Locations

  • Planned Parenthood Columbia Willamette

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo-cherry syrup and ibuprofen

Midazolam and ibuprofen

Arm Description

5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine

5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine

Outcomes

Primary Outcome Measures

Subject Perception of Pain and Anxiety During Uterine Aspiration
Subjects will be asked to rate anxiety and pain at the time of uterine aspiration by marking along a 100 mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety

Secondary Outcome Measures

Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline
Subjects will be asked to rate their anticipated anxiety and pain at the time of uterine aspiration by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Subject Perception of Pain and Anxiety Upon Entering Procedure Room
Subjects will be asked to rate anxiety and pain upon entering procedure room by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Subject Perception of Pain and Anxiety Post Procedure
Subjects will be asked to rate anxiety and pain 30 minutes post-operatively by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Subject Perception of Anxiety With Patient Positioning Procedure
Subjects will be asked to rate anxiety prior to starting pelvic exam by marking along a mm Visual Analog Scale, with 0mm being No Anxiety and 100mm being Worst Imaginable Anxiety
Subject Perception of Pain During Cervical Dilation
Subjects will be asked to rate pain at the time of cervical dilation by marking along a mm Visual Analog Scale, with 0mm being No Pain and 100mm being Worst Imaginable Pain
State-Trait Anxiety Inventory for Anxiety at Baseline
To measure the mean State-Trait Anxiety Inventory (STAI) Form Y-1 for anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." Each type of anxiety has its own 4-point scale of 20 different questions that are scored. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always. Scores range from 20 to 80, with higher scores indicate greater anxiety. State anxiety items and Trait anxiety items were each summed in assessment to provide two total scores for each participant, a State anxiety score and a Trait anxiety score. Mean and standard deviation of total scores for each group are reported.
Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively
To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 30 min postoperatively as measured by a mm Visual Analog Scale with 0mm being Not At All Satisfied and 100mm being Very Satisfied
Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure
To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 1-3 days postoperatively as measured by a mm VAS with 0mm being Not At All Satisfied and 100mm being Very Satisfied
Subject Extent of Amnesia Using Amnesia Score
To assess the extent of amnesia 30 min postoperatively as measured by ability to recall procedure using 4-point scale (0 = unable to recall any proportion of the procedure, 1 = able to recall and describe some portions of the procedure, but overall has minimal recall of the procedure, 2 = able to recall and describe most of the procedure, but admits to inability to recall some portion of the procedure, 3 = able to recall and describe the entire procedure).
Subject Extent of Amnesia
To assess the extent of amnesia 1-3 days postoperatively as measured by 100mm Visual Analog Scale with 0mm being Remember Nothing and 100mm being Remember Everything.
Subject Extent of Sedation
Subject extent of sedation 30-60 minutes after premedication, just prior to procedure as measured by the 6-point Ramsay Scale (1 = patient anxious agitated, or restless; 2 = patient cooperative, oriented, and tranquil; 3 = patient asleep, responds to commands only; 4 = patient asleep, responds to gentle shaking, light glabellar tap, or loud auditory stimulus; 5 = patient asleep, responds to noxious stimuli such as firm nail bed pressure; 6 = patient asleep, has no response to firm nail bed pressure or other noxious stimuli)
Subject Vital Signs (Heart Rate)
Subject heart rate will be assessed for the duration of the procedure
Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure
Subject vital signs (heart rate) will be assessed 30 minutes postoperatively
Subject Nausea 30 Minutes Postprocedure
Subject nausea will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable
Subject's Correct Identification of Receiving Midazolam or Placebo
Number of patient's who could correctly determine if they received study drug or placebo when asked
Subject Vital Signs (Oxygenation Saturation)
Subject oxygenation status will be assessed for the duration of the procedure
Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure
Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively
Subject Sleepiness 30 Minutes Postprocedure
Subject sleepiness will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable
Number of Participants With Need for Additional Postoperative Pain Medication
Subjects will be assessed 30 minutes postoperatively for need of additional pain medications.

Full Information

First Posted
April 3, 2013
Last Updated
June 20, 2018
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01830881
Brief Title
Evaluation of Oral Midazolam in First-trimester Surgical Abortions
Official Title
An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.
Detailed Description
Women in the study will be randomized to receive either midazolam or placebo. Every participant will still receive the standard oral medications for pain (ibuprofen) as well as an injection of numbing medicine (lidocaine) near the cervix (PCB). The co-primary outcomes are patient perception of anxiety and pain with uterine aspiration reported on a 100 mm visual analogue scale (VAS). Secondary outcomes include reported anxiety and pain at time points before, during, and after the procedure, as well as subject satisfaction with anxiety and pain control and overall abortion experience. Due to the dose-dependent anterograde amnesic effect of midazolam, we will also investigate the effects on memory and recall, which has not previously been studied. In addition, we will also collect data on side effects frequently associated with oral midazolam such as nausea and sleepiness. Women will also be responsible for completing a one-page survey 1-3 days after the procedure visit and return it by mail using a pre-addressed and stamped envelope.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Nausea
Keywords
pain, anxiety, surgical abortion, midazolam, benzodiazepine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo-cherry syrup and ibuprofen
Arm Type
Placebo Comparator
Arm Description
5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Arm Title
Midazolam and ibuprofen
Arm Type
Active Comparator
Arm Description
5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin
Intervention Description
800 mg oral ibuprofen 30-60 minutes prior to procedure
Intervention Type
Other
Intervention Name(s)
Placebo-Cherry syrup
Other Intervention Name(s)
placebo cherry syrup
Intervention Description
5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
lidocaine injection
Intervention Description
injection of 20 mL 1% lidocaine without epinephrine
Primary Outcome Measure Information:
Title
Subject Perception of Pain and Anxiety During Uterine Aspiration
Description
Subjects will be asked to rate anxiety and pain at the time of uterine aspiration by marking along a 100 mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Time Frame
at time of uterine aspiration (30-60 minutes after premedication)
Secondary Outcome Measure Information:
Title
Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline
Description
Subjects will be asked to rate their anticipated anxiety and pain at the time of uterine aspiration by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Time Frame
Baseline (upon entry into study)
Title
Subject Perception of Pain and Anxiety Upon Entering Procedure Room
Description
Subjects will be asked to rate anxiety and pain upon entering procedure room by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Time Frame
upon entering procedure room (30-60 minutes after premedication)
Title
Subject Perception of Pain and Anxiety Post Procedure
Description
Subjects will be asked to rate anxiety and pain 30 minutes post-operatively by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety
Time Frame
30 minutes post operatively
Title
Subject Perception of Anxiety With Patient Positioning Procedure
Description
Subjects will be asked to rate anxiety prior to starting pelvic exam by marking along a mm Visual Analog Scale, with 0mm being No Anxiety and 100mm being Worst Imaginable Anxiety
Time Frame
prior to starting pelvic exam (30-60 minutes after premedication)
Title
Subject Perception of Pain During Cervical Dilation
Description
Subjects will be asked to rate pain at the time of cervical dilation by marking along a mm Visual Analog Scale, with 0mm being No Pain and 100mm being Worst Imaginable Pain
Time Frame
with cervical dilation (30-60 minutes after premedication)
Title
State-Trait Anxiety Inventory for Anxiety at Baseline
Description
To measure the mean State-Trait Anxiety Inventory (STAI) Form Y-1 for anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." Each type of anxiety has its own 4-point scale of 20 different questions that are scored. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always. Scores range from 20 to 80, with higher scores indicate greater anxiety. State anxiety items and Trait anxiety items were each summed in assessment to provide two total scores for each participant, a State anxiety score and a Trait anxiety score. Mean and standard deviation of total scores for each group are reported.
Time Frame
Baseline (upon entry into study)
Title
Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively
Description
To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 30 min postoperatively as measured by a mm Visual Analog Scale with 0mm being Not At All Satisfied and 100mm being Very Satisfied
Time Frame
30 minutes post-operatively
Title
Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure
Description
To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 1-3 days postoperatively as measured by a mm VAS with 0mm being Not At All Satisfied and 100mm being Very Satisfied
Time Frame
1-3 days post-operatively
Title
Subject Extent of Amnesia Using Amnesia Score
Description
To assess the extent of amnesia 30 min postoperatively as measured by ability to recall procedure using 4-point scale (0 = unable to recall any proportion of the procedure, 1 = able to recall and describe some portions of the procedure, but overall has minimal recall of the procedure, 2 = able to recall and describe most of the procedure, but admits to inability to recall some portion of the procedure, 3 = able to recall and describe the entire procedure).
Time Frame
30 minutes postoperatively
Title
Subject Extent of Amnesia
Description
To assess the extent of amnesia 1-3 days postoperatively as measured by 100mm Visual Analog Scale with 0mm being Remember Nothing and 100mm being Remember Everything.
Time Frame
1-3 days postoperatively
Title
Subject Extent of Sedation
Description
Subject extent of sedation 30-60 minutes after premedication, just prior to procedure as measured by the 6-point Ramsay Scale (1 = patient anxious agitated, or restless; 2 = patient cooperative, oriented, and tranquil; 3 = patient asleep, responds to commands only; 4 = patient asleep, responds to gentle shaking, light glabellar tap, or loud auditory stimulus; 5 = patient asleep, responds to noxious stimuli such as firm nail bed pressure; 6 = patient asleep, has no response to firm nail bed pressure or other noxious stimuli)
Time Frame
30-60 minutes after premedication
Title
Subject Vital Signs (Heart Rate)
Description
Subject heart rate will be assessed for the duration of the procedure
Time Frame
intraoperatively (30-60 minutes after premedication)
Title
Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure
Description
Subject vital signs (heart rate) will be assessed 30 minutes postoperatively
Time Frame
30 minutes postoperatively
Title
Subject Nausea 30 Minutes Postprocedure
Description
Subject nausea will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable
Time Frame
30 minutes postoperatively
Title
Subject's Correct Identification of Receiving Midazolam or Placebo
Description
Number of patient's who could correctly determine if they received study drug or placebo when asked
Time Frame
30 minutes postoperatively
Title
Subject Vital Signs (Oxygenation Saturation)
Description
Subject oxygenation status will be assessed for the duration of the procedure
Time Frame
intraoperatively (30-60 minutes after premedication)
Title
Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure
Description
Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively
Time Frame
30 minutes postoperatively
Title
Subject Sleepiness 30 Minutes Postprocedure
Description
Subject sleepiness will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable
Time Frame
30 minutes postoperatively
Title
Number of Participants With Need for Additional Postoperative Pain Medication
Description
Subjects will be assessed 30 minutes postoperatively for need of additional pain medications.
Time Frame
30 minutes postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Voluntarily requesting surgical pregnancy termination Pregnancy with intrauterine gestational sac between 6 0/7 and 10 6/7 weeks gestation, dated by ultrasound Eligible for suction aspiration English or Spanish speaking Good general health Able and willing to give informed consent and agree to terms of the study Have assistance home; no driving for 24 hours Exclusion Criteria: - Gestational ages 11 0/7 weeks or more Gestational age less than 6 0/7 weeks Incomplete abortion Premedication with misoprostol Use of narcotic pain or anti-anxiety medication within past 24 hours Use of heroin or methadone within last 3 months Chronic alcoholism or alcohol intoxication within past 24 hours Requested narcotics or Intravenous sedation (prior to randomization) Allergic reaction or allergy to cherry/cherry flavoring or lidocaine or non-steroidal anti-inflammatory drugs (NSAIDs) Allergic reaction or sensitivity to benzodiazepines including hyperactive or aggressive behavior (paradoxical reaction) Medical problem necessitating inpatient procedure Untreated acute cervicitis or pelvic inflammatory disease Known acute narrow-angle glaucoma Weighing less than 100 lb (45 kg) Use of potent medications interfering with microsomal metabolism within past 48 hours (carbamazepine (Tegretol), cimetidine (Tagamet), diltiazem (Cardizem), erythromycin, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), nelfinavir, ranitidine (Zantac), rifampin (Rifadin), ritonavir (Norvir), saquinavir, verapamil (Calan))
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Bayer, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood Columbia Willamette
City
Portland
State/Province
Oregon
ZIP/Postal Code
97206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26241254
Citation
Bayer LL, Edelman AB, Fu R, Lambert WE, Nichols MD, Bednarek PH, Miller K, Jensen JT. An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):37-46. doi: 10.1097/AOG.0000000000000913.
Results Reference
derived

Learn more about this trial

Evaluation of Oral Midazolam in First-trimester Surgical Abortions

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