OSDI: Oral Sedation During Cervical Dilator Placement

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03202550
• Collaborator: Society of Family Planning (Other)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Oral Sedation and Cervical Dilator Pain	Drug: Oxycodone and Lorazepam (Active Comparator); Drug: Placebo Comparator	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial
• Actual Study Start Date: Jun 28, 2017
• Actual Primary Completion Date: May 28, 2019
• Actual Study Completion Date: May 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Arm Two oral placebo pills (microcrystalline cellulose capsules)	Drug: Placebo Comparator; Placebo oral pills
Active Comparator: Active Drug Arm: Lorazepam and Oxycodone 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)	Drug: Oxycodone and Lorazepam (Active Comparator); Oxycodone and Lorazepam; Other Names: Oral Oxycodone Oral Lorazepam Ativan OxyIR Roxicodone

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. 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)

8. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins' Women's Center for Family Planning	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• Society of Family Planning

Investigators

• Principal Investigator: Carolyn Sufrin, Johns Hopkins University
• Principal Investigator: Jessica K Lee, MD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 17, 2018

More Information

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.
• 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.
• Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21.
• 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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03202550
• Other Study ID Numbers: IRB00117627
• First Posted: Jun 28, 2017
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Johns Hopkins University: Oral Sedation; Lorazepam; Oxycodone
• Additional relevant MeSH terms: Oxycodone; Lorazepam

Study Results

Participant Flow

Pre-assignment Detail	Three participants who were enrolled but did not receive the intervention had either chosen not to proceed further with the study or were not able to swallow the study drugs.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Period Title: Overall Study
STARTED	13	11
COMPLETED	13	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone	Total
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam	Total of all reporting groups
Overall Participants	13	11	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 100%	11 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	13 100%	11 100%	24 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.7%	0 0%	1 4.2%
Not Hispanic or Latino	12 92.3%	11 100%	23 95.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 84.6%	10 90.9%	21 87.5%
White	1 7.7%	0 0%	1 4.2%
More than one race	0 0%	1 9.1%	1 4.2%
Unknown or Not Reported	1 7.7%	0 0%	1 4.2%
Region of Enrollment (Count of Participants)
United States	13 100%	11 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	Immediately after the last dilator is placed, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	55	44

2. Secondary Outcome

Title	Number of Participants With Desired Number of Dilators Inserted
Description	Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.
Time Frame	After speculum removed, up to 30 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Count of Participants [Participants]	13 100%	10 90.9%

3. Secondary Outcome

Title	Baseline Pain Score Before Drugs Were Administered
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	pain score given prior to administration of study drugs, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	3	2

4. Secondary Outcome

Title	Pain Score Before Speculum Placement
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	pain score given before specula placed, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	1	1

5. Secondary Outcome

Title	Pain Score After Speculum Placement
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	pain score given at time of speculum placement, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	20	11

6. Secondary Outcome

Title	Pain Score at Tenaculum Placement
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	Immediately scored at time of tenacula placement, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	31	50

7. Secondary Outcome

Title	Pain Score During Paracervical Block
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	pain score given at time of paracervical block administration, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	57	51

8. Secondary Outcome

Title	Pain Score After First Dilator Placement
Description	Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)
Time Frame	pain score given immediately after first dilator placed, up to 1 minute

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	50	9

9. Secondary Outcome

Title	Pain Score 15 Minutes After Last Dilator Placed
Description	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).
Time Frame	Assessed up to 45 minutes after last dilator placed

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo Arm	Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Measure Participants	13	10
Median (Inter-Quartile Range) [units on a scale]	29	13

Adverse Events

Time Frame	Adverse event data was collected from subjects for the 1 day that they were enrolled and active in the study.
Arm/Group Title	Placebo Arm		Active Drug Arm: Lorazepam and Oxycodone
Arm/Group Description	Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills		1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules) Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
All Cause Mortality
	Placebo Arm		Active Drug Arm: Lorazepam and Oxycodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Serious Adverse Events
	Placebo Arm		Active Drug Arm: Lorazepam and Oxycodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Arm		Active Drug Arm: Lorazepam and Oxycodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		0/11 (0%)
Reproductive system and breast disorders
Cervical laceration	1/13 (7.7%)	1	0/11 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.