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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | Two oral placebo pills (microcrystalline cellulose capsules) |
|
| Active Drug Arm: Lorazepam and Oxycodone | Active Comparator | 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone and Lorazepam (Active Comparator) | Drug | Oxycodone and Lorazepam |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Immediately after the last dilator is placed, up to 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After speculum removed, up to 30 minutes |
| Baseline Pain Score Before Drugs Were Administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Sufrin | Johns Hopkins University | Principal Investigator |
| Jessica K Lee, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins' Women's Center for Family Planning | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25139724 | Background | Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23. | |
| Background | Soon, R. T., M.; Salcedo. J.; Kaneshiro, B., Paracervical block to decrease pain with second-trimester laminaria insertion: a randomized controlled trial. Contraception 2016, 94 (4), 389. | ||
| 11980742 |
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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.
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Three participants who were enrolled but did not receive the intervention had either chosen not to proceed further with the study or were not able to swallow the study drugs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills |
| FG001 | Active Drug Arm: Lorazepam and Oxycodone | 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills |
| BG001 | Active Drug Arm: Lorazepam and Oxycodone | 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after the last dilator is placed, up to 1 minute |
|
Adverse event data was collected from subjects for the 1 day that they were enrolled and active in the study.
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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 Arm | Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical laceration | Reproductive system and breast disorders | Systematic Assessment | Laceration occurred when tenaculum was placed on cervix |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrina Thaler | Johns Hopkins University | 410-550-8506 | kstouff3@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2018 | Feb 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Randomized controlled trial
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The participant, provider, and nursing staff will be blinded to the intervention. The pharmacy will prepare the treatment drugs and placebos.. Randomization will be stratified by gestational age (>= 20 weeks or <20 weeks) and the randomization allocation sequence will be computer-generated with a random number generator by a statistician. The pharmacist will be aware of the randomization sequence and will dispense the drugs as appropriate, while keeping track of which arms participants were randomized to.
| Placebo Comparator | Drug | Placebo oral pills |
|
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
| 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) | 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) | 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) | 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) | 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) | 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). | Assessed up to 45 minutes after last dilator placed |
| Background |
| Wong CY, Ng EH, Ngai SW, Ho PC. A randomized, double blind, placebo-controlled study to investigate the use of conscious sedation in conjunction with paracervical block for reducing pain in termination of first trimester pregnancy by suction evacuation. Hum Reprod. 2002 May;17(5):1222-5. doi: 10.1093/humrep/17.5.1222. |
| 12618257 | Background | Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. doi: 10.1016/s0010-7824(02)00516-4. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)
Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
|
|
| Secondary | 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. | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Count of Participants | Participants | After speculum removed, up to 30 minutes |
|
|
|
| Secondary | 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) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | pain score given prior to administration of study drugs, up to 1 minute |
|
|
|
| Secondary | Pain Score Before Speculum Placement | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | pain score given before specula placed, up to 1 minute |
|
|
|
| Secondary | Pain Score After Speculum Placement | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | pain score given at time of speculum placement, up to 1 minute |
|
|
|
| Secondary | Pain Score at Tenaculum Placement | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately scored at time of tenacula placement, up to 1 minute |
|
|
|
| Secondary | Pain Score During Paracervical Block | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | pain score given at time of paracervical block administration, up to 1 minute |
|
|
|
| Secondary | 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) | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | pain score given immediately after first dilator placed, up to 1 minute |
|
|
|
| Secondary | 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). | One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants. | Posted | Median | Inter-Quartile Range | units on a scale | Assessed up to 45 minutes after last dilator placed |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Active Drug Arm: Lorazepam and Oxycodone | 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam | 0 | 11 | 0 | 11 | 0 | 11 |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |