Evaluation of Oral Midazolam in First-trimester Surgical Abortions

Pain Clinical Trial

Official title:

An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830881
• Other study ID #: OHSU IRB 9064
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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))

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Nausea
• Pain

Intervention

Drug:
• 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

Other:
• Placebo-Cherry syrup
5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure

Drug:
• Lidocaine
injection of 20 mL 1% lidocaine without epinephrine

Locations

Country	Name	City	State
United States	Planned Parenthood Columbia Willamette	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	at time of uterine aspiration (30-60 minutes after premedication)
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	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	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	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	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	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.	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	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	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).	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.	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)	30-60 minutes after premedication
Secondary	Subject Vital Signs (Heart Rate)	Subject heart rate will be assessed for the duration of the procedure	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	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	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	30 minutes postoperatively
Secondary	Subject Vital Signs (Oxygenation Saturation)	Subject oxygenation status will be assessed for the duration of the procedure	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	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	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.	30 minutes postoperatively