Clinical trial NCT03202550: Oral Sedation During Cervical Dilator Placement
Official title: Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Sedation and Cervical Dilator Pain
Keywords: Oral Sedation
Lorazepam
Oxycodone
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2017-06-28
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
timeFrame: Immediately after the last dilator is placed, up to 1 minute
Secondary outcomes:
measure: Number of Participants With Desired Number of Dilators Inserted
timeFrame: After speculum removed, up to 30 minutes
measure: Baseline Pain Score Before Drugs Were Administered
timeFrame: pain score given prior to administration of study drugs, up to 1 minute
measure: Pain Score Before Speculum Placement
timeFrame: pain score given before specula placed, up to 1 minute
measure: Pain Score After Speculum Placement
timeFrame: pain score given at time of speculum placement, up to 1 minute
measure: Pain Score at Tenaculum Placement
timeFrame: Immediately scored at time of tenacula placement, up to 1 minute
measure: Pain Score During Paracervical Block
timeFrame: pain score given at time of paracervical block administration, up to 1 minute
measure: Pain Score After First Dilator Placement
timeFrame: pain score given immediately after first dilator placed, up to 1 minute
measure: Pain Score 15 Minutes After Last Dilator Placed
timeFrame: Assessed up to 45 minutes after last dilator placed
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins' Women's Center for Family Planning
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Carolyn Sufrin
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Jessica K Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
citation: Soon, R. T., M.; Salcedo. J.; Kaneshiro, B., Paracervical block to decrease pain with second-trimester laminaria insertion: a randomized controlled trial. Contraception 2016, 94 (4), 389.
citation: Wong CY, Ng EH, Ngai SW, Ho PC. A randomized, double blind, placebo-controlled study to investigate the use of conscious sedation in conjunction with paracervical block for reducing pain in termination of first trimester pregnancy by suction evacuation. Hum Reprod. 2002 May;17(5):1222-5. doi: 10.1093/humrep/17.5.1222.
citation: Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. doi: 10.1016/s0010-7824(02)00516-4.