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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Oxycodone and Lorazepam
Placebo oral pills
Johns Hopkins' Women's Center for Family Planning
Baltimore, Maryland, United States
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
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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