PainPhase 4NCT01830881
Evaluation of Oral Midazolam in First-trimester Surgical Abortions
A Phase 4 study testing Midazolam, Ibuprofen and Lidocaine in people with Pain and Anxiety, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- What is being tested?
- Midazolam, Ibuprofen and Lidocaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 15Show fewer
- 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))
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Columbia Willamette
Portland, Oregon, 97206
About this study
Official title: An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
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.
Read the 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.
- Keywords
- pain, anxiety, surgical abortion, midazolam, benzodiazepine
- Medical subject headings
- Pain, Anxiety Disorders, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Versed
5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
IbuprofenDrug
Also called Motrin
800 mg oral ibuprofen 30-60 minutes prior to procedure
Placebo-Cherry syrupOther
Also called placebo cherry syrup
5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
LidocaineDrug
Also called lidocaine injection
injection of 20 mL 1% lidocaine without epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ibuprofen; Other: Placebo-Cherry syrup; Drug: Lidocaine |
| 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 Receives: Drug: Midazolam; Drug: Ibuprofen; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at time of uterine aspiration (30-60 minutes after premedication)
Secondary outcomes (19)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 30-60 minutes after premedication
Subject Vital Signs (Heart Rate)
Subject heart rate will be assessed for the duration of the procedure
Measured: 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
Measured: 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
Measured: 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
Measured: 30 minutes postoperatively
Subject Vital Signs (Oxygenation Saturation)
Subject oxygenation status will be assessed for the duration of the procedure
Measured: 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
Measured: 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
Measured: 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.
Measured: 30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Bayer, MD MPH, Oregon Health and Science University
- Investigators
- Lisa Bayer, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830881
- Sponsor's protocol ID
- OHSU IRB 9064
- Status last verified
- Jun 2018
- First submitted
- 3 Apr 2013
- Last updated
- 25 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26241254
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01830881
- Acronym / sponsor ID
- OHSU IRB 9064
- Keywords
- pain, anxiety, surgical abortion, midazolam, benzodiazepine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo-cherry syrup and ibuprofen | Placebo comparator | Drug: Ibuprofen, Other: Placebo-Cherry syrup, Drug: Lidocaine5 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 | Drug: Midazolam, Drug: Ibuprofen, Drug: Lidocaine5 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Versed5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure | Drug | Midazolam and ibuprofen |
| IbuprofenAlso: Motrin800 mg oral ibuprofen 30-60 minutes prior to procedure | Drug | Midazolam and ibuprofen, placebo-cherry syrup and ibuprofen |
| Placebo-Cherry syrupAlso: placebo cherry syrup5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure | Other | placebo-cherry syrup and ibuprofen |
| LidocaineAlso: lidocaine injectioninjection of 20 mL 1% lidocaine without epinephrine | Drug | Midazolam and ibuprofen, placebo-cherry syrup and ibuprofen |
Primary outcome
Subject Perception of Pain and Anxiety During Uterine Aspiration
Time frame: 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
19 secondary outcomes
Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline
Time frame: Baseline (upon entry into study)
Subject Perception of Pain and Anxiety Upon Entering Procedure Room
Time frame: upon entering procedure room (30-60 minutes after premedication)
Subject Perception of Pain and Anxiety Post Procedure
Time frame: 30 minutes post operatively
Subject Perception of Anxiety With Patient Positioning Procedure
Time frame: prior to starting pelvic exam (30-60 minutes after premedication)
Subject Perception of Pain During Cervical Dilation
Time frame: with cervical dilation (30-60 minutes after premedication)
State-Trait Anxiety Inventory for Anxiety at Baseline
Time frame: Baseline (upon entry into study)
Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively
Time frame: 30 minutes post-operatively
Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure
Time frame: 1-3 days post-operatively
Subject Extent of Amnesia Using Amnesia Score
Time frame: 30 minutes postoperatively
Subject Extent of Amnesia
Time frame: 1-3 days postoperatively
Subject Extent of Sedation
Time frame: 30-60 minutes after premedication
Subject Vital Signs (Heart Rate)
Time frame: intraoperatively (30-60 minutes after premedication)
Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure
Time frame: 30 minutes postoperatively
Subject Nausea 30 Minutes Postprocedure
Time frame: 30 minutes postoperatively
Subject's Correct Identification of Receiving Midazolam or Placebo
Time frame: 30 minutes postoperatively
Subject Vital Signs (Oxygenation Saturation)
Time frame: intraoperatively (30-60 minutes after premedication)
Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure
Time frame: 30 minutes postoperatively
Subject Sleepiness 30 Minutes Postprocedure
Time frame: 30 minutes postoperatively
Number of Participants With Need for Additional Postoperative Pain Medication
Time frame: 30 minutes postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26241254Bayer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Bayer, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam, Ibuprofen and Lidocaine in people with Pain and Anxiety, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Perception of Pain and Anxiety During Uterine Aspiration (time frame: at time of uterine aspiration (30-60 minutes after premedication)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01830881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.