Oral Sedation During Cervical Dilator Placement

Study Overview
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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).

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.

Official Title
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Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial

Conditions
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Oral Sedation and Cervical Dilator Pain

Intervention / Treatment
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* Drug: Oxycodone and Lorazepam (Active Comparator)
* Drug: Placebo Comparator


Participation Criteria
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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) Exclusion Criteria: Non-English-speaking Taking a daily benzodiazepine or opiate Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>Two oral placebo pills (microcrystalline cellulose capsules) | Drug: Placebo Comparator<br>* Placebo oral pills<br>|
| Active Comparator: Active Drug Arm: Lorazepam and Oxycodone<br>1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) | Drug: Oxycodone and Lorazepam (Active Comparator)<br>* Oxycodone and Lorazepam<br>* Other names: Roxicodone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Immediately after the last dilator is placed, up to 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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) | 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) | 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) | Immediately scored at time of tenacula placement, up to 1 minute | 
| Pain Score During Paracervical Block | Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) | 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) | 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). | Assessed up to 45 minutes after last dilator placed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Sedation, Lorazepam, Oxycodone