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Oral Sedation During Cervical Dilator Placement (OSDI)

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ClinicalTrials.gov Identifier: NCT03202550
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Oral Sedation and Cervical Dilator Pain Drug: Oxycodone and Lorazepam (Active Comparator) Drug: Placebo Comparator Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Arm
Two oral placebo pills (microcrystalline cellulose capsules)
Drug: Placebo Comparator
Placebo oral pills

Active Comparator: Active Drug Arm: Lorazepam and Oxycodone
1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)
Drug: Oxycodone and Lorazepam (Active Comparator)
Oxycodone and Lorazepam
Other Names:
  • Oral Oxycodone
  • Oral Lorazepam
  • Ativan
  • OxyIR
  • Roxicodone




Primary Outcome Measures :
  1. Cervical dilator placement pain as assessed by VAS on a tablet device [ 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)


Secondary Outcome Measures :
  1. Procedure Time for Dilator Placement [ Time Frame: Time of speculum placement to the time of last dilator placement, up to 20 minutes. ]
    Assess procedure time for cervical dilator placement, comparing 2 arms

  2. Number of dilators inserted [ Time Frame: After speculum removed, up to 30 minutes ]
    Assess whether desired number (or more than desired) of dilators were successfully inserted, comparing 2 arms. Up to 13 dilators

  3. Dilator Pain Experience after Placement [ Time Frame: 2 hours after dilator placement ]
    Compare pain scores on a 10 point numeric rating scale (NRS) (anchors 0=no pain; 10=worst pain ever) after dilator placement via text messaging

  4. Dilator Pain Experience after Placement [ Time Frame: 4 hours after dilator placement ]
    Compare pain scores on a 10 point numeric rating scale (NRS) (anchors 0=no pain; 10=worst pain ever) after dilator placement via text messaging

  5. Dilator Pain Experience after Placement [ Time Frame: 8 hours after dilator placement ]
    Compare pain scores on a 10 point numeric rating scale (NRS) (anchors 0=no pain; 10=worst pain ever) after dilator placement via text messaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202550


Contacts
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Contact: Jessica K Lee, MD 410-550-8506 jlee574@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins' Women's Center for Family Planning Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jessica K Lee, MD       jlee574@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Society of Family Planning

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03202550     History of Changes
Other Study ID Numbers: IRB00117627
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study plans to share placebo data (without PHI) with colleagues at University of California Davis at the end of the study. A Memorandum of Understanding will be created prior to sharing (MOU) and data will be shared across a secure server.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Johns Hopkins University:
Oral Sedation
Lorazepam
Oxycodone

Additional relevant MeSH terms:
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Oxycodone
Lorazepam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action