Oral Sedation During Cervical Dilator Placement (OSDI)

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Oral Sedation and Cervical Dilator Pain

Treatments: Drug: Placebo Comparator; Drug: Oxycodone and Lorazepam (Active Comparator)

Study type: Interventional

Funder types: Other

Identifiers

NCT03202550

IRB00117627

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

Two oral placebo pills (microcrystalline cellulose capsules)

Treatment:

Drug: Placebo Comparator

Active Drug Arm: Lorazepam and Oxycodone

Active Comparator group

Description:

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

Treatment:

Drug: Oxycodone and Lorazepam (Active Comparator)