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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo-cherry syrup and ibuprofen | Placebo Comparator | 5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine |
|
| Midazolam and ibuprofen | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at time of uterine aspiration (30-60 minutes after premedication) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (upon entry into study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Bayer, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Columbia Willamette | Portland | Oregon | 97206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26241254 | Derived | 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. |
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This randomized, double-blind, placebo-controlled trial was conducted at Planned Parenthood Columbia/ Willamette in Portland, Oregon, between May 2013 and December 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | mm | at time of uterine aspiration (30-60 minutes after premedication) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reaspiration | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Bayer, MD | Oregon Health and Science University | 503-494-3666 | whru@gmail.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D007052 | Ibuprofen |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ibuprofen | Drug | 800 mg oral ibuprofen 30-60 minutes prior to procedure |
|
|
| Placebo-Cherry syrup | Other | 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure |
|
|
| Lidocaine | Drug | injection of 20 mL 1% lidocaine without epinephrine |
|
|
| 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 | 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 | 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 | prior to starting pelvic exam (30-60 minutes after premedication) |
| 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 | 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. | 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 | 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 | 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). | 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. | 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) | 30-60 minutes after premedication |
| Subject Vital Signs (Heart Rate) | Subject heart rate will be assessed for the duration of the procedure | 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 | 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 | 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 | 30 minutes postoperatively |
| Subject Vital Signs (Oxygenation Saturation) | Subject oxygenation status will be assessed for the duration of the procedure | 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 | 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 | 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. | 30 minutes postoperatively |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Parity | Number | participants |
|
| Previous vaginal deliveries | Number | participants |
|
| Previous surgical abortion | Number | participants |
|
| Level of menstrual symptoms | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Self-reported depression | Number | participants |
|
| Self-reported anxiety | Number | participants |
|
| OG001 | 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 |
|
|
| 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 | Posted | Mean | Standard Deviation | mm | Baseline (upon entry into study) |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mm | upon entering procedure room (30-60 minutes after premedication) |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mm | 30 minutes post operatively |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mm | prior to starting pelvic exam (30-60 minutes after premedication) |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mm | with cervical dilation (30-60 minutes after premedication) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (upon entry into study) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm on a 100 mm Visual Analog Scale | 30 minutes post-operatively |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm on a 100 mm Visual Analog Scale | 1-3 days post-operatively |
|
|
|
| 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). | Posted | Count of Participants | Participants | 30 minutes postoperatively |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mm | 1-3 days postoperatively |
|
|
|
| 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) | 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. | Posted | Count of Participants | Participants | 30-60 minutes after premedication |
|
|
|
| Secondary | Subject Vital Signs (Heart Rate) | Subject heart rate will be assessed for the duration of the procedure | 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. | Posted | Mean | Full Range | bmp | intraoperatively (30-60 minutes after premedication) |
|
|
|
| Secondary | Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure | Subject vital signs (heart rate) will be assessed 30 minutes postoperatively | 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. | Posted | Mean | Standard Deviation | bpm | 30 minutes postoperatively |
|
|
|
| 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 | Posted | Mean | Full Range | 100-mm visual analog sclae for nausea | 30 minutes postoperatively |
|
|
|
| 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 | Posted | Count of Participants | Participants | 30 minutes postoperatively |
|
|
|
| Secondary | Subject Vital Signs (Oxygenation Saturation) | Subject oxygenation status will be assessed for the duration of the procedure | Posted | Mean | Standard Deviation | percent saturation | intraoperatively (30-60 minutes after premedication) |
|
|
|
| Secondary | Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure | Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively | Posted | Mean | Standard Deviation | percent saturation | 30 minutes postoperatively |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 30 minutes postoperatively |
|
|
|
| Secondary | Number of Participants With Need for Additional Postoperative Pain Medication | Subjects will be assessed 30 minutes postoperatively for need of additional pain medications. | One participant in the Midazolam group left the study. One participant in the placebo group decided not to have the procedure. | Posted | Count of Participants | Participants | 30 minutes postoperatively |
|
|
|
| 0 |
| 62 |
| 2 |
| 62 |
| EG001 | 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 | 0 | 62 | 3 | 62 |
| Cervical laceration | Surgical and medical procedures |
|
| Hemorrhage | Surgical and medical procedures |
|
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| D012817 | Signs and Symptoms, Digestive |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| 3 |
|
| 4 or greater |
|