Trial Outcomes & Findings for Oral Sedation During Cervical Dilator Placement (NCT NCT03202550)

NCT ID: NCT03202550

Last Updated: 2020-03-30

Results Overview

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

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

Results posted on

2020-03-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Placebo Arm Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone 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
Overall Study STARTED	13	11
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Sedation During Cervical Dilator Placement

Baseline characteristics by cohort

PRIMARY outcome

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

Population: 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.

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device	55 units on a scale Interval 33.0 to 82.0	44 units on a scale Interval 10.0 to 80.0

SECONDARY outcome

Timeframe: After speculum removed, up to 30 minutes

Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Number of Participants With Desired Number of Dilators Inserted	13 Participants	10 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Baseline Pain Score Before Drugs Were Administered	3 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Pain Score Before Speculum Placement	1 units on a scale Interval 0.0 to 1.0	1 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Pain Score After Speculum Placement	20 units on a scale Interval 12.0 to 43.0	11 units on a scale Interval 3.0 to 51.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Pain Score at Tenaculum Placement	31 units on a scale Interval 15.0 to 56.0	50 units on a scale Interval 2.0 to 70.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Pain Score During Paracervical Block	57 units on a scale Interval 16.0 to 69.0	51 units on a scale Interval 6.0 to 71.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Pain Score After First Dilator Placement	50 units on a scale Interval 16.0 to 56.0	9 units on a scale Interval 2.0 to 52.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=10 Participants 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
Pain Score 15 Minutes After Last Dilator Placed	29 units on a scale Interval 14.0 to 44.0	13 units on a scale Interval 0.0 to 49.0

Adverse Events

Placebo Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Active Drug Arm: Lorazepam and Oxycodone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Arm n=13 participants at risk Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=11 participants at risk 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
Reproductive system and breast disorders Cervical laceration	7.7% 1/13 • Number of events 1 • Adverse event data was collected from subjects for the 1 day that they were enrolled and active in the study.	0.00% 0/11 • Adverse event data was collected from subjects for the 1 day that they were enrolled and active in the study.

Additional Information

Katrina Thaler

Johns Hopkins University

Phone: 410-550-8506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo Arm n=13 Participants Two oral placebo pills (microcrystalline cellulose capsules) Placebo Comparator: Placebo oral pills	Active Drug Arm: Lorazepam and Oxycodone n=11 Participants 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 n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants