Anxiety, Nausea, Pain
Conditions
Keywords
pain, anxiety, surgical abortion, midazolam, benzodiazepine
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.
Interventions
DRUGMidazolam
5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
DRUGIbuprofen
800 mg oral ibuprofen 30-60 minutes prior to procedure
OTHERPlacebo-Cherry syrup
5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
DRUGLidocaine
injection of 20 mL 1% lidocaine without epinephrine
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Perception of Pain and Anxiety During Uterine Aspiration | at time of uterine aspiration (30-60 minutes after premedication) | 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
| Measure | Time frame | Description |
|---|---|---|
| Subject Perception of Pain and Anxiety Upon Entering Procedure Room | upon entering procedure room (30-60 minutes after premedication) | 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 | 30 minutes post operatively | 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 | prior to starting pelvic exam (30-60 minutes after premedication) | 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 | with cervical dilation (30-60 minutes after premedication) | 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 | Baseline (upon entry into study) | 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 | 30 minutes post-operatively | 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 | 1-3 days post-operatively | 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 | 30 minutes postoperatively | 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 | 1-3 days postoperatively | 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 Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline | Baseline (upon entry into study) | 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 Vital Signs (Heart Rate) | intraoperatively (30-60 minutes after premedication) | Subject heart rate will be assessed for the duration of the procedure |
| Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure | 30 minutes postoperatively | Subject vital signs (heart rate) will be assessed 30 minutes postoperatively |
| Subject Nausea 30 Minutes Postprocedure | 30 minutes postoperatively | 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 | 30 minutes postoperatively | Number of patient's who could correctly determine if they received study drug or placebo when asked |
| Subject Vital Signs (Oxygenation Saturation) | intraoperatively (30-60 minutes after premedication) | Subject oxygenation status will be assessed for the duration of the procedure |
| Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure | 30 minutes postoperatively | Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively |
| Subject Sleepiness 30 Minutes Postprocedure | 30 minutes postoperatively | 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 | 30 minutes postoperatively | Subjects will be assessed 30 minutes postoperatively for need of additional pain medications. |
| Subject Extent of Sedation | 30-60 minutes after premedication | 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) |
Countries
United States
Participant flow
Recruitment details
This randomized, double-blind, placebo-controlled trial was conducted at Planned Parenthood Columbia/ Willamette in Portland, Oregon, between May 2013 and December 2013.
Participants by arm
| Arm | Count |
|---|---|
| Placebo-cherry Syrup and Ibuprofen 5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine | 62 |
| Midazolam and Ibuprofen 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
Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure
Lidocaine: injection of 20 mL 1% lidocaine without epinephrine | 62 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changed decision to have an abortion | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo-cherry Syrup and Ibuprofen | Midazolam and Ibuprofen | Total |
|---|---|---|---|
| Age, Continuous | 25.8 years STANDARD_DEVIATION 5.3 | 25.5 years STANDARD_DEVIATION 5.8 | 25.6 years STANDARD_DEVIATION 5.5 |
| BMI | 25.9 kg/m2 STANDARD_DEVIATION 6 | 25.9 kg/m2 STANDARD_DEVIATION 5.5 | 25.9 kg/m2 STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 8 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 54 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Level of menstrual symptoms Easy or mild cramping | 30 participants | 40 participants | 70 participants |
| Level of menstrual symptoms Requiring medication or unable to attend work | 32 participants | 22 participants | 54 participants |
| Parity Nulliparous | 38 participants | 32 participants | 70 participants |
| Parity Parous | 24 participants | 30 participants | 54 participants |
| Previous surgical abortion No | 41 participants | 39 participants | 80 participants |
| Previous surgical abortion Yes | 21 participants | 23 participants | 44 participants |
| Previous vaginal deliveries No | 42 participants | 40 participants | 82 participants |
| Previous vaginal deliveries Yes | 20 participants | 22 participants | 42 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 13 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 42 Participants | 86 Participants |
| Self-reported anxiety No | 48 participants | 48 participants | 96 participants |
| Self-reported anxiety Yes | 14 participants | 14 participants | 28 participants |
| Self-reported depression No | 43 participants | 48 participants | 91 participants |
| Self-reported depression Yes | 19 participants | 14 participants | 33 participants |
| Sex: Female, Male Female | 62 Participants | 62 Participants | 124 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 62 | 3 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
Primary
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)
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain and Anxiety During Uterine Aspiration | Pain with Aspiration | 74.3 mm | Standard Deviation 20.6 |
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain and Anxiety During Uterine Aspiration | Anxiety with Aspiration | 68.2 mm | Standard Deviation 28.1 |
| Midazolam and Ibuprofen | Subject Perception of Pain and Anxiety During Uterine Aspiration | Pain with Aspiration | 70.1 mm | Standard Deviation 22.1 |
| Midazolam and Ibuprofen | Subject Perception of Pain and Anxiety During Uterine Aspiration | Anxiety with Aspiration | 60.9 mm | Standard Deviation 27.3 |
Secondary
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
Population: One participant in the Midazolam group left the study. One participant in the placebo group decided not to have the procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Number of Participants With Need for Additional Postoperative Pain Medication | Ondansetron | 3 Participants |
| Placebo-cherry Syrup and Ibuprofen | Number of Participants With Need for Additional Postoperative Pain Medication | Hydrocodone/acetaminophen | 2 Participants |
| Midazolam and Ibuprofen | Number of Participants With Need for Additional Postoperative Pain Medication | Ondansetron | 2 Participants |
| Midazolam and Ibuprofen | Number of Participants With Need for Additional Postoperative Pain Medication | Hydrocodone/acetaminophen | 1 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively | Satisfaction with anxiety control (100-mm VAS) | 56.1 mm on a 100 mm Visual Analog Scale | Standard Deviation 29.6 |
| Placebo-cherry Syrup and Ibuprofen | Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively | Satisfaction with pain control (100-mm VAS) | 43.2 mm on a 100 mm Visual Analog Scale | Standard Deviation 30.7 |
| Midazolam and Ibuprofen | Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively | Satisfaction with anxiety control (100-mm VAS) | 68.9 mm on a 100 mm Visual Analog Scale | Standard Deviation 24.7 |
| Midazolam and Ibuprofen | Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively | Satisfaction with pain control (100-mm VAS) | 50.0 mm on a 100 mm Visual Analog Scale | Standard Deviation 27.3 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | State-Trait Anxiety Inventory for Anxiety at Baseline | State anxiety level | 50.8 units on a scale | Standard Deviation 11 |
| Placebo-cherry Syrup and Ibuprofen | State-Trait Anxiety Inventory for Anxiety at Baseline | Trait anxiety level | 40.1 units on a scale | Standard Deviation 10.8 |
| Midazolam and Ibuprofen | State-Trait Anxiety Inventory for Anxiety at Baseline | State anxiety level | 51.3 units on a scale | Standard Deviation 9.7 |
| Midazolam and Ibuprofen | State-Trait Anxiety Inventory for Anxiety at Baseline | Trait anxiety level | 38.6 units on a scale | Standard Deviation 9.7 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline | Expected Anxiety | 77.5 mm | Standard Deviation 20.6 |
| Placebo-cherry Syrup and Ibuprofen | Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline | Expected Pain | 67.2 mm | Standard Deviation 19.7 |
| Midazolam and Ibuprofen | Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline | Expected Anxiety | 74.2 mm | Standard Deviation 20.1 |
| Midazolam and Ibuprofen | Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline | Expected Pain | 69.2 mm | Standard Deviation 17.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Amnesia | 91.5 mm | Standard Deviation 12.8 |
| Midazolam and Ibuprofen | Subject Extent of Amnesia | 61.3 mm | Standard Deviation 25.8 |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Amnesia Using Amnesia Score | Partial to complete amnesia (score 0,1,2) | 16 Participants |
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Amnesia Using Amnesia Score | No Amnesia (score 3) | 45 Participants |
| Midazolam and Ibuprofen | Subject Extent of Amnesia Using Amnesia Score | Partial to complete amnesia (score 0,1,2) | 31 Participants |
| Midazolam and Ibuprofen | Subject Extent of Amnesia Using Amnesia Score | No Amnesia (score 3) | 30 Participants |
Secondary
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
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Sedation | 1 | 11 Participants |
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Sedation | 3 | 0 Participants |
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Sedation | 2 | 50 Participants |
| Placebo-cherry Syrup and Ibuprofen | Subject Extent of Sedation | 4 or greater | 0 Participants |
| Midazolam and Ibuprofen | Subject Extent of Sedation | 4 or greater | 0 Participants |
| Midazolam and Ibuprofen | Subject Extent of Sedation | 1 | 10 Participants |
| Midazolam and Ibuprofen | Subject Extent of Sedation | 2 | 51 Participants |
| Midazolam and Ibuprofen | Subject Extent of Sedation | 3 | 1 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Nausea 30 Minutes Postprocedure | 9.5 100-mm visual analog sclae for nausea |
| Midazolam and Ibuprofen | Subject Nausea 30 Minutes Postprocedure | 3.5 100-mm visual analog sclae for nausea |
Secondary
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)
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Anxiety With Patient Positioning Procedure | 56.6 mm | Standard Deviation 26.4 |
| Midazolam and Ibuprofen | Subject Perception of Anxiety With Patient Positioning Procedure | 45.4 mm | Standard Deviation 26.3 |
Secondary
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
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain and Anxiety Post Procedure | Anxiety Post Procedure | 20.9 mm | Standard Deviation 22.6 |
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain and Anxiety Post Procedure | Pain Post Procedure | 34.7 mm | Standard Deviation 23.3 |
| Midazolam and Ibuprofen | Subject Perception of Pain and Anxiety Post Procedure | Anxiety Post Procedure | 14.4 mm | Standard Deviation 13.5 |
| Midazolam and Ibuprofen | Subject Perception of Pain and Anxiety Post Procedure | Pain Post Procedure | 37.1 mm | Standard Deviation 24.6 |
Secondary
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)
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain and Anxiety Upon Entering Procedure Room | Anxiety at Room Entry | 51.4 mm | Standard Deviation 25.4 |
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain and Anxiety Upon Entering Procedure Room | Pain at Room Entry | 17.5 mm | Standard Deviation 21.1 |
| Midazolam and Ibuprofen | Subject Perception of Pain and Anxiety Upon Entering Procedure Room | Anxiety at Room Entry | 34.5 mm | Standard Deviation 22.9 |
| Midazolam and Ibuprofen | Subject Perception of Pain and Anxiety Upon Entering Procedure Room | Pain at Room Entry | 10.1 mm | Standard Deviation 15.4 |
Secondary
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)
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Perception of Pain During Cervical Dilation | 73.0 mm | Standard Deviation 21.2 |
| Midazolam and Ibuprofen | Subject Perception of Pain During Cervical Dilation | 69.3 mm | Standard Deviation 19.9 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure | Satisfaction with anxiety control (100-mm VAS) | 50.2 mm on a 100 mm Visual Analog Scale | Standard Deviation 31.7 |
| Placebo-cherry Syrup and Ibuprofen | Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure | Satisfaction with pain control (100-mm VAS) | 36.6 mm on a 100 mm Visual Analog Scale | Standard Deviation 30.8 |
| Midazolam and Ibuprofen | Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure | Satisfaction with anxiety control (100-mm VAS) | 64.7 mm on a 100 mm Visual Analog Scale | Standard Deviation 28.2 |
| Midazolam and Ibuprofen | Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure | Satisfaction with pain control (100-mm VAS) | 48.2 mm on a 100 mm Visual Analog Scale | Standard Deviation 30.1 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject's Correct Identification of Receiving Midazolam or Placebo | 43 Participants |
| Midazolam and Ibuprofen | Subject's Correct Identification of Receiving Midazolam or Placebo | 48 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Sleepiness 30 Minutes Postprocedure | 40.1 units on a scale | Standard Deviation 29.3 |
| Midazolam and Ibuprofen | Subject Sleepiness 30 Minutes Postprocedure | 56.6 units on a scale | Standard Deviation 24.6 |
Secondary
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)
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Vital Signs (Heart Rate) | 80 bmp |
| Midazolam and Ibuprofen | Subject Vital Signs (Heart Rate) | 78.5 bmp |
Secondary
Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure
Subject vital signs (heart rate) will be assessed 30 minutes postoperatively
Time frame: 30 minutes postoperatively
Population: 1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure | 70.1 bpm | Standard Deviation 12.4 |
| Midazolam and Ibuprofen | Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure | 72 bpm | Standard Deviation 11.8 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Vital Signs (Oxygenation Saturation) | 98.3 percent saturation | Standard Deviation 1.2 |
| Midazolam and Ibuprofen | Subject Vital Signs (Oxygenation Saturation) | 98.1 percent saturation | Standard Deviation 1 |
Secondary
Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure
Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively
Time frame: 30 minutes postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-cherry Syrup and Ibuprofen | Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure | 98.3 percent saturation | Standard Deviation 1.2 |
| Midazolam and Ibuprofen | Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure | 98.1 percent saturation | Standard Deviation 1 |