Oral Sedation During Cervical Dilator Placement

NCT03202550 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00117627
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Oral Sedation and Cervical Dilator Pain

Keywords

Oral Sedation; Lorazepam; Oxycodone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants With Desired Number of Dilators Inserted

  After speculum removed, up to 30 minutes

• Baseline Pain Score Before Drugs Were Administered

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

• Pain Score Before Speculum Placement

  pain score given before specula placed, up to 1 minute

• Pain Score After Speculum Placement

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

• Pain Score at Tenaculum Placement

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

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Two oral placebo pills (microcrystalline cellulose capsules)

Drug: Placebo Comparator

Active Drug Arm: Lorazepam and Oxycodone

ACTIVE COMPARATOR

1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)

Drug: Oxycodone and Lorazepam (Active Comparator)

Interventions

Oxycodone and Lorazepam (Active Comparator) DRUG

Oxycodone and Lorazepam

Also known as: Oral Oxycodone, Oral Lorazepam, Ativan, OxyIR, Roxicodone

Active Drug Arm: Lorazepam and Oxycodone

Placebo Comparator DRUG

Placebo oral pills

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Non-English-speaking
• Taking a daily benzodiazepine or opiate
• Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines

Sponsors & Collaborators

• Johns Hopkins University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Johns Hopkins' Women's Center for Family Planning

Baltimore, Maryland, 21224, United States

Location

Related Publications (4)

• 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.

  PMID: 25139724 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11980742 BACKGROUND

• 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.

  PMID: 12618257 BACKGROUND

MeSH Terms

Interventions

Oxycodone; Lorazepam

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Katrina Thaler
• Organization: Johns Hopkins University

kstouff3@jhmi.edu

410-550-8506

Study Officials

• Carolyn Sufrin

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Jessica K Lee, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: June 28, 2017
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: March 30, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)