Johns Hopkins' Women's Center for Family Planning
Baltimore, Maryland, 21224, United States
NCT Number: NCT03202550
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).
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Notify Me18 year–50 year
Female
Interventional
Phase 4
Baltimore, Maryland, 21224, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxycodone and Lorazepam
Other names: Oral Oxycodone, Oral Lorazepam, Ativan, OxyIR, Roxicodone
Placebo oral pills
Time frame: 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)
Time frame: After speculum removed, up to 30 minutes
Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Johns Hopkins University
Other
Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
Acronym: OSDI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.