Oral Sedation During Cervical Dilator Placement

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2019-05-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Oral Sedation and Cervical Dilator Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Placebo Arm

Two oral placebo pills (microcrystalline cellulose capsules)

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Placebo oral pills

Active Drug Arm: Lorazepam and Oxycodone

1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)

Group Type ACTIVE_COMPARATOR

Oxycodone and Lorazepam (Active Comparator)

Intervention Type DRUG

Oxycodone and Lorazepam

Interventions

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Oxycodone and Lorazepam (Active Comparator)

Oxycodone and Lorazepam

Intervention Type DRUG

Placebo Comparator

Placebo oral pills

Intervention Type DRUG

Other Intervention Names

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Oral Oxycodone Oral Lorazepam Ativan OxyIR Roxicodone

Eligibility Criteria

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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)