Oral Sedation During Cervical Dilator Placement
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/8/2018 |
| Start Date: | June 28, 2017 |
| End Date: | July 15, 2019 |
| Contact: | Jessica K Lee, MD |
| Email: | jlee574@jhmi.edu |
| Phone: | 410-550-8506 |
Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
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).
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.
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.
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 them
- 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
We found this trial at
1
site
Click here to add this to my saved trials
