Trial Outcomes & Findings for Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial (NCT NCT03080493)
NCT ID: NCT03080493
Last Updated: 2020-04-14
Results Overview
Pain score based on numeric rating scale (NRS \[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
8 hours after insertion of last osmotic dilator
Results posted on
2020-04-14
Participant Flow
Participant milestones
| Measure |
Gabapentin
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
60
|
58
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Gabapentin
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Overall Study
Did not provide NRS pain results
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Randomization error (parity group)
|
0
|
1
|
Baseline Characteristics
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Gabapentin
n=60 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=58 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
26.2 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 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
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Declined
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Reasons for abortion
Unwanted pregnancy
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Reasons for abortion
Fetal anomalies
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Not completed high school
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
High school or equivalent
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Education
Some college
|
16 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Education
College or higher
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Declined
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hours after insertion of last osmotic dilatorPopulation: Women who responded with pain scores by text using Numeric Rating Scale
Pain score based on numeric rating scale (NRS \[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Outcome measures
| Measure |
Gabapentin
n=58 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=52 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion
|
2 Numeric rating scale pain score change
Interval -3.0 to 8.0
|
2.5 Numeric rating scale pain score change
Interval -5.0 to 10.0
|
SECONDARY outcome
Timeframe: 5 minutes after insertion of last osmotic dilatorPopulation: Women who provided Numeric rating scale pain score
Pain score based on numeric rating scale (NRS \[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment.
Outcome measures
| Measure |
Gabapentin
n=60 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=58 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion
|
1 Numeric rating scale pain score change
Interval -6.0 to 10.0
|
2 Numeric rating scale pain score change
Interval -5.0 to 8.0
|
SECONDARY outcome
Timeframe: 2 hours after insertion of last osmotic dilatorPopulation: Women who responded by text with numeric pain scale score
Pain score based on numeric rating scale (NRS \[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Outcome measures
| Measure |
Gabapentin
n=54 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=54 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion
|
3.5 Numeric rating scale pain score change
Interval -8.0 to 9.0
|
4 Numeric rating scale pain score change
Interval -2.0 to 10.0
|
SECONDARY outcome
Timeframe: 4 hours after insertion of last osmotic dilatorPopulation: Women who responded by text with numeric pain scale score
Pain score based on numeric rating scale (NRS \[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Outcome measures
| Measure |
Gabapentin
n=56 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=50 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion
|
3 Numeric rating scale pain score change
Interval -8.0 to 9.0
|
3.5 Numeric rating scale pain score change
Interval -3.0 to 10.0
|
SECONDARY outcome
Timeframe: Time of presentation for D&E (day after dilator insertion)Population: Women who provided numeric pain scale scores
Pain score based on numeric rating scale (NRS \[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D\&E procedure.
Outcome measures
| Measure |
Gabapentin
n=60 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=58 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)
|
0.5 Numeric rating scale pain score change
Interval -8.0 to 7.0
|
1 Numeric rating scale pain score change
Interval -2.0 to 9.0
|
SECONDARY outcome
Timeframe: Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)Population: Any use of narcotics
Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)
Outcome measures
| Measure |
Gabapentin
n=60 Participants
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=58 Participants
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)
|
35 Participants
|
40 Participants
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=60 participants at risk
Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
Placebo Oral Capsule
n=58 participants at risk
Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight
Placebo oral capsule: Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofen: Over the counter analgesic medications
|
|---|---|---|
|
Nervous system disorders
Dizziness at baseline
|
1.7%
1/60 • Number of events 1 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
0.00%
0/58 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
Nervous system disorders
Dizziness at 5 minutes after dilator placement
|
35.0%
21/60 • Number of events 21 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
25.9%
15/58 • Number of events 15 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
Nervous system disorders
Dizzines at 2 hours after dilator placement
|
54.7%
29/53 • Number of events 29 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
20.8%
11/53 • Number of events 11 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
Nervous system disorders
Dizziness at 4 hours after dilator placement
|
40.0%
22/55 • Number of events 22 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
10.0%
5/50 • Number of events 5 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
Nervous system disorders
Dizziness at 8 hours after dilator placement
|
26.3%
15/57 • Number of events 15 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
5.8%
3/52 • Number of events 3 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
Nervous system disorders
Dizziness at 18-24 hours after dilator placement
|
5.0%
3/60 • Number of events 3 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
6.9%
4/58 • Number of events 4 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
General disorders
Tiredness at baseline
|
11.7%
7/60 • Number of events 7 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
6.9%
4/58 • Number of events 4 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
General disorders
Tiredness at 5 minutes after dilator placement
|
11.7%
7/60 • Number of events 7 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
20.7%
12/58 • Number of events 12 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
General disorders
Tiredness at 2 hours after dilator placement
|
63.0%
34/54 • Number of events 34 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
31.5%
17/54 • Number of events 17 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
General disorders
Tiredness at 4 hours after dilator placement
|
68.5%
37/54 • Number of events 37 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
35.3%
18/51 • Number of events 18 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
General disorders
Tiredness at 8 hours after dilator placement
|
38.6%
22/57 • Number of events 22 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
33.3%
17/51 • Number of events 17 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
|
General disorders
Tiredness at 18-24 hours after dilator placment
|
30.0%
18/60 • Number of events 18 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
37.9%
22/58 • Number of events 22 • One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place