A Phase 4 interventional study of Oxycodone and Lorazepam (Active Comparator) and Placebo Comparator in Oral Sedation and Cervical Dilator Pain, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Treatment
This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D\&E).
Potential participants will be first introduced to the study via routine intake call. Participants will be identified at the participant's office visits to the Johns Hopkins' Women's Center for Family Planning. If a patient desires D\&E for a second trimester pregnancy, the patient will first receive standard counseling. Only after providing written informed consent for the procedure will the patients be screened for eligibility in the study. If the patient is eligible the participant will be asked by a member of the research team if the patient is interested in participating. If the patient is, the study will be explained to the participant and written consent will be obtained after participant is given the opportunity to have all questions answered.
The study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.
Participants in both arms will receive the institution's current standard analgesia for cervical dilator placement. In addition to this standard regimen, participants will be randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two oral placebo pills (microcrystalline cellulose capsules)
Drug: Placebo Comparator
1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)
Drug: Oxycodone and Lorazepam (Active Comparator)
Oxycodone and Lorazepam
Also known as: Oral Oxycodone, Oral Lorazepam, Ativan, OxyIR, Roxicodone
Placebo oral pills
Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: Immediately after the last dilator is placed, up to 1 minute
Number of Participants With Desired Number of Dilators Inserted
Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.
Time frame: After speculum removed, up to 30 minutes
Baseline Pain Score Before Drugs Were Administered
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: pain score given prior to administration of study drugs, up to 1 minute
Pain Score Before Speculum Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: pain score given before specula placed, up to 1 minute
Pain Score After Speculum Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: pain score given at time of speculum placement, up to 1 minute
Pain Score at Tenaculum Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: Immediately scored at time of tenacula placement, up to 1 minute
Pain Score During Paracervical Block
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: pain score given at time of paracervical block administration, up to 1 minute
Pain Score After First Dilator Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time frame: pain score given immediately after first dilator placed, up to 1 minute
Pain Score 15 Minutes After Last Dilator Placed
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark).
Time frame: Assessed up to 45 minutes after last dilator placed
| Milestone | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Started | 13 | 11 |
| Completed | 13 | 11 |
| Not completed | 0 | 0 |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device | 55 (33 to 82) | 44 (10 to 80) |
Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.
| Participants | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Number of Participants With Desired Number of Dilators Inserted | 13 | 10 |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Baseline Pain Score Before Drugs Were Administered | 3 (0 to 6) | 2 (0 to 12) |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Pain Score Before Speculum Placement | 1 (0 to 1) | 1 (0 to 2) |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Pain Score After Speculum Placement | 20 (12 to 43) | 11 (3 to 51) |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Pain Score at Tenaculum Placement | 31 (15 to 56) | 50 (2 to 70) |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Pain Score During Paracervical Block | 57 (16 to 69) | 51 (6 to 71) |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Pain Score After First Dilator Placement | 50 (16 to 56) | 9 (2 to 52) |
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark).
| units on a scale | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Pain Score 15 Minutes After Last Dilator Placed | 29 (14 to 44) | 13 (0 to 49) |
Collected over Adverse event data was collected from subjects for the 1 day that they were enrolled and active in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Arm | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Active Drug Arm: Lorazepam and Oxycodone | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone |
|---|---|---|
| Cervical lacerationReproductive system and breast disorders | 1/13 | 0/11 |
| Age, Categorical(Participants) | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 11 | 24 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 10 | 21 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone | Total |
|---|---|---|---|
| United States | 13 | 11 | 24 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The study plans to share placebo data (without PHI) with colleagues at University of California Davis at the end of the study. A Memorandum of Understanding will be created prior to sharing (MOU) and data will be shared across a secure server.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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