Oral Sedation During Cervical Dilator Placement

Phase 4

Completed

Conditions: Oral Sedation and Cervical Dilator Pain

Interventions: Drug: Placebo Comparator
Drug: Oxycodone and Lorazepam (Active Comparator)

Registration Number: NCT03202550

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 27

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo Comparator	Two oral placebo pills (microcrystalline cellulose capsules)
Active Drug Arm: Lorazepam and Oxycodone	Oxycodone and Lorazepam (Active Comparator)	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)

Primary Outcome Measures

Name	Time	Method
Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device	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

Name	Time	Method
Pain Score Before Speculum Placement	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)
Baseline Pain Score Before Drugs Were Administered	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)
Pain Score After First Dilator Placement	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)
Pain Score at Tenaculum Placement	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)
Pain Score 15 Minutes After Last Dilator Placed	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).
Number of Participants With Desired Number of Dilators Inserted	After speculum removed, up to 30 minutes	Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.
Pain Score After Speculum Placement	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)
Pain Score During Paracervical Block	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)