Oral Sedation and Cervical Dilator PainPhase 4OSDINCT03202550

Oral Sedation During Cervical Dilator Placement

A Phase 4 study testing Oxycodone and Lorazepam (Active Comparator) in people with Oral Sedation and Cervical Dilator Pain, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Oral Sedation and Cervical Dilator Pain
What is being tested?: Oxycodone and Lorazepam (Active Comparator)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 28 Jun 2017to 28 May 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins' Women's Center for Family Planning
Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial

Read the 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.

Conditions: Oral Sedation and Cervical Dilator Pain
Being tested: Oxycodone and Lorazepam (Active Comparator), Placebo Comparator
Keywords: Oral Sedation, Lorazepam, Oxycodone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone and Lorazepam (Active Comparator)Drug
Also called Oral Oxycodone, Oral Lorazepam, Ativan, OxyIR
Oxycodone and Lorazepam
Placebo ComparatorDrug
Placebo oral pills

Study groups in NCT03202550
Study group	Role	What they receive
Placebo Arm	Placebo comparator	Two oral placebo pills (microcrystalline cellulose capsules) Receives: 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) Receives: Drug: Oxycodone and Lorazepam (Active Comparator)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Immediately after the last dilator is placed, up to 1 minute

Secondary outcomes (8)

Number of Participants With Desired Number of Dilators Inserted
Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.
Measured: After speculum removed, up to 30 minutes
Baseline Pain Score Before Drugs Were Administered
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Measured: pain score given prior to administration of study drugs, up to 1 minute
Pain Score Before Speculum Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Measured: pain score given before specula placed, up to 1 minute
Pain Score After Speculum Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Measured: pain score given at time of speculum placement, up to 1 minute
Pain Score at Tenaculum Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Measured: Immediately scored at time of tenacula placement, up to 1 minute
Pain Score During Paracervical Block
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Measured: pain score given at time of paracervical block administration, up to 1 minute
Pain Score After First Dilator Placement
Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Measured: pain score given immediately after first dilator placed, up to 1 minute
Pain Score 15 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).
Measured: Assessed up to 45 minutes after last dilator placed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201728 May 2019

First posted28 Jun 2017
Study start28 Jun 2017
Primary completion28 May 2019
Study completion28 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Oral Sedation and Cervical Dilator PainStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03202550
Sponsor's protocol ID: IRB00117627
Acronym: OSDI
Status last verified: Mar 2020
First submitted: 27 Jun 2017
Last updated: 30 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 25139724
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.
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.
PubMed 11980742
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.
PubMed 12618257

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03202550
Acronym / sponsor ID: OSDI / IRB00117627
Conditions: Oral Sedation and Cervical Dilator Pain
Keywords: Oral Sedation, Lorazepam, Oxycodone
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Society of Family Planning
Study start: 28 Jun 2017 (actual)
Primary completion: 28 May 2019 (actual)
Study completion: 28 May 2019 (actual)
First posted: 28 Jun 2017 (actual)
Results: Posted 6 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled trial

Arm	Type	Receives
Placebo Arm	Placebo comparator	Drug: Placebo ComparatorTwo oral placebo pills (microcrystalline cellulose capsules)
Active Drug Arm: Lorazepam and Oxycodone	Active comparator	Drug: Oxycodone and Lorazepam (Active Comparator)1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxycodone and Lorazepam (Active Comparator)Also: Oral Oxycodone, Oral Lorazepam, Ativan, OxyIROxycodone and Lorazepam	Drug	Active Drug Arm: Lorazepam and Oxycodone
Placebo ComparatorPlacebo oral pills	Drug	Placebo Arm

Primary outcome

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)

8 secondary outcomes

Number of Participants With Desired Number of Dilators Inserted
Time frame: After speculum removed, up to 30 minutes
Baseline Pain Score Before Drugs Were Administered
Time frame: pain score given prior to administration of study drugs, up to 1 minute
Pain Score Before Speculum Placement
Time frame: pain score given before specula placed, up to 1 minute
Pain Score After Speculum Placement
Time frame: pain score given at time of speculum placement, up to 1 minute
Pain Score at Tenaculum Placement
Time frame: Immediately scored at time of tenacula placement, up to 1 minute
Pain Score During Paracervical Block
Time frame: pain score given at time of paracervical block administration, up to 1 minute
Pain Score After First Dilator Placement
Time frame: pain score given immediately after first dilator placed, up to 1 minute
Pain Score 15 Minutes After Last Dilator Placed
Time frame: Assessed up to 45 minutes after last dilator placed

Results and safety

Results posted to the registry on 6 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Arm	13	13
Active Drug Arm: Lorazepam and Oxycodone	11	11

Primary outcome: 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. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Placebo Arm n = 13	Active Drug Arm: Lorazepam and Oxycodone n = 10
Value	55 (33 to 82)	44 (10 to 80)

Population analysed: One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from subjects for the 1 day that they were enrolled and active in the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Arm	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Active Drug Arm: Lorazepam and Oxycodone	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25139724Mercier 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.
BackgroundSoon, 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: PubMed 11980742Wong 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.
Background: PubMed 12618257Wiebe 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.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolyn Sufrin principal investigator

Johns Hopkins University

Jessica K Lee, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone and Lorazepam (Active Comparator) in people with Oral Sedation and Cervical Dilator Pain, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03202550, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.