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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
800 mg oral ibuprofen 30-60 minutes prior to procedure
5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Planned Parenthood Columbia Willamette
Portland, Oregon, United States
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
Time frame: at time of uterine aspiration (30-60 minutes after premedication)
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
Time frame: Baseline (upon entry into study)
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
Time frame: upon entering procedure room (30-60 minutes after premedication)
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
Time frame: 30 minutes post operatively
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
Time frame: prior to starting pelvic exam (30-60 minutes after premedication)
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injection of 20 mL 1% lidocaine without epinephrine
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
Time frame: with cervical dilation (30-60 minutes after premedication)
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.
Time frame: Baseline (upon entry into study)
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
Time frame: 30 minutes post-operatively
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
Time frame: 1-3 days post-operatively
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).
Time frame: 30 minutes postoperatively
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.
Time frame: 1-3 days postoperatively
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)
Time frame: 30-60 minutes after premedication
Subject Vital Signs (Heart Rate)
Subject heart rate will be assessed for the duration of the procedure
Time frame: intraoperatively (30-60 minutes after premedication)
Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure
Subject vital signs (heart rate) will be assessed 30 minutes postoperatively
Time frame: 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
Time frame: 30 minutes postoperatively
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
Time frame: 30 minutes postoperatively
Subject Vital Signs (Oxygenation Saturation)
Subject oxygenation status will be assessed for the duration of the procedure
Time frame: intraoperatively (30-60 minutes after premedication)
Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure
Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively
Time frame: 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
Time frame: 30 minutes postoperatively
Number of Participants With Need for Additional Postoperative Pain Medication
Subjects will be assessed 30 minutes postoperatively for need of additional pain medications.
Time frame: 30 minutes postoperatively