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Completed

NCT Number: NCT03202550

Oral Sedation During Cervical Dilator Placement

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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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins' Women's Center for Family Planning

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone and Lorazepam (Active Comparator)

Drug

Oxycodone and Lorazepam

Other names: Oral Oxycodone, Oral Lorazepam, Ativan, OxyIR, Roxicodone

placebo comparator

Drug

Placebo oral pills

Primary outcomes

  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 outcomes

  1. Number of Participants With Desired Number of Dilators Inserted

    Time frame: After speculum removed, up to 30 minutes

    Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.

  2. Baseline Pain Score Before Drugs Were Administered

    Time frame: pain score given prior to administration of study drugs, up to 1 minute

    Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

  3. Pain Score Before Speculum Placement

    Time frame: pain score given before specula placed, up to 1 minute

    Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

  4. Pain Score After Speculum Placement

    Time frame: pain score given at time of speculum placement, up to 1 minute

    Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

  5. Pain Score at Tenaculum Placement

    Time frame: Immediately scored at time of tenacula placement, up to 1 minute

    Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

  6. Pain Score During Paracervical Block

    Time frame: pain score given at time of paracervical block administration, up to 1 minute

    Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

  7. Pain Score After First Dilator Placement

    Time frame: pain score given immediately after first dilator placed, up to 1 minute

    Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

  8. Pain Score 15 Minutes After Last Dilator Placed

    Time frame: Assessed up to 45 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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial

Acronym: OSDI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.