Oral Sedation and Cervical Dilator Pain
Conditions
Keywords
Oral Sedation, Lorazepam, Oxycodone
Brief summary
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).
Detailed description
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.
Interventions
DRUGOxycodone and Lorazepam (Active Comparator)
Oxycodone and Lorazepam
DRUGPlacebo Comparator
Placebo oral pills
Sponsors
Society of Family Planning
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-50 years * English speaking * With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d * Have a support person present with participant * Have a cell phone capable of text messaging (optional)
Exclusion criteria
* Non-English-speaking * Taking a daily benzodiazepine or opiate * Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device | Immediately after the last dilator is placed, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Pain Score Before Drugs Were Administered | pain score given prior to administration of study drugs, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
| Pain Score Before Speculum Placement | pain score given before specula placed, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
| Pain Score After Speculum Placement | pain score given at time of speculum placement, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
| Number of Participants With Desired Number of Dilators Inserted | After speculum removed, up to 30 minutes | Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms. |
| Pain Score During Paracervical Block | pain score given at time of paracervical block administration, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
| Pain Score After First Dilator Placement | pain score given immediately after first dilator placed, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
| Pain Score 15 Minutes After Last Dilator Placed | Assessed up to 45 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). |
| Pain Score at Tenaculum Placement | Immediately scored at time of tenacula placement, up to 1 minute | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Arm Two oral placebo pills (microcrystalline cellulose capsules)
Placebo Comparator: Placebo oral pills | 13 |
| 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 | 11 |
| Total | 24 |
Baseline characteristics
| Characteristic | Placebo Arm | Active Drug Arm: Lorazepam and Oxycodone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 11 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 10 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 1 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
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)
Time frame: Immediately after the last dilator is placed, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device | 55 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device | 44 units on a scale |
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)
Time frame: pain score given prior to administration of study drugs, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Baseline Pain Score Before Drugs Were Administered | 3 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Baseline Pain Score Before Drugs Were Administered | 2 units on a scale |
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.
Time frame: After speculum removed, up to 30 minutes
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Arm | Number of Participants With Desired Number of Dilators Inserted | 13 Participants |
| Active Drug Arm: Lorazepam and Oxycodone | Number of Participants With Desired Number of Dilators Inserted | 10 Participants |
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).
Time frame: Assessed up to 45 minutes after last dilator placed
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Pain Score 15 Minutes After Last Dilator Placed | 29 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Pain Score 15 Minutes After Last Dilator Placed | 13 units on a scale |
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)
Time frame: pain score given immediately after first dilator placed, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Pain Score After First Dilator Placement | 50 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Pain Score After First Dilator Placement | 9 units on a scale |
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)
Time frame: pain score given at time of speculum placement, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Pain Score After Speculum Placement | 20 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Pain Score After Speculum Placement | 11 units on a scale |
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)
Time frame: Immediately scored at time of tenacula placement, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Pain Score at Tenaculum Placement | 31 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Pain Score at Tenaculum Placement | 50 units on a scale |
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)
Time frame: pain score given before specula placed, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Pain Score Before Speculum Placement | 1 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Pain Score Before Speculum Placement | 1 units on a scale |
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)
Time frame: pain score given at time of paracervical block administration, up to 1 minute
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Arm | Pain Score During Paracervical Block | 57 units on a scale |
| Active Drug Arm: Lorazepam and Oxycodone | Pain Score During Paracervical Block | 51 units on a scale |