GABA: Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
Study Details
Study Description
Brief Summary
Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after women go home they expand slowly overnight to open the cervix before the abortion procedure the next day. This can be a painful experience and health care providers often give women different kinds of pain medicine to help them.
The investigators are interested in whether a medicine called gabapentin, which is a non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are also using it to decrease pain for people having surgical procedures.
The main goals of our study are to learn about:
-
Women's pain experience with dilators in their cervix overnight before the abortion procedure
-
How well gabapentin works to decrease women's pain while they have the dilators in their cervix
Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no medicine in it) before their dilators are placed in the clinic. The medication they get (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in the study nor the doctors giving them the medication will know which medication they receive so the investigators can learn about their pain without being influenced by knowing which medication they take. Doctors will be able to find out which medication women got if there is an emergency or if it changes their medical care.
The investigators will communicate with women in real time overnight by text messaging to see how much pain they are having in the moment and how much pain medicine they are taking.
The investigators hypothesize that women who receive gabapentin will have a smaller increase in their pain with the dilators than women who receive placebo (a pill with no medicine in it).
The investigators' findings will help doctors understand women's pain experience with dilators better and possibly provide a new way of treating pain with gabapentin.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
The investigators have planned a double-blind randomized controlled trial of repeated doses of gabapentin compared to placebo for pain management during the time after dilator insertion and prior to D&E the subsequent day.
-
Participants will receive gabapentin 600 mg or placebo prior to dilator insertion
-
Pain scores will be measured via numeric rating scale (NRS) at baseline and 5 minutes after last dilator insertion while the participant is in clinic
-
Additional pain scores, side effects (specifically dizziness and sedation), and additional analgesic use will be obtained by text message while the patient is home at 2 hours, 4 hours, and 8 hours after time of dilator insertion
-
Subjects will take a second dose of study drug (either gabapentin 600 mg or placebo, concordant with their initial medication) at 8 hours after their first dose
-
Final pain score, side effect, and analgesic use assessment will occur upon presentation to the pre-operative are for D&E the subsequent day
There will be no change in standard insertion of osmotic dilators (hygroscopic dilators only with Lidocaine 20mL cervical anesthesia), or provision of home analgesic medications (ibuprofen and acetaminophen with codeine in our practice).
The investigators hypothesize that women who receive gabapentin will report a smaller increase in pain from baseline at 8 hours after dilator placement compared to women receiving placebo.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 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 |
Drug: Gabapentin 600mg
Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
Other Names:
Drug: acetaminophen/codeine and ibuprofen
Over the counter analgesic medications
Other Names:
|
Placebo Comparator: Placebo oral capsule Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight |
Drug: Placebo oral capsule
Packaged identical to gabapentin dosing
Other Names:
Drug: acetaminophen/codeine and ibuprofen
Over the counter analgesic medications
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion [8 hours after insertion of last osmotic dilator]
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.
Secondary Outcome Measures
- Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion [5 minutes after insertion of last osmotic dilator]
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.
- Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion [2 hours after insertion of last osmotic dilator]
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.
- Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion [4 hours after insertion of last osmotic dilator]
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.
- Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion) [Time of presentation for D&E (day after dilator insertion)]
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.
- Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine) [Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)]
Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
15 weeks 0 days gestational age - 23 weeks 5 days gestational age at time of dilator insertion
-
Able to read and write in English
-
Active cell phone with text messaging capability
-
Ride home from dilator insertion clinic appointment
Exclusion Criteria:
-
Current use of gabapentin or pregabalin
-
Allergy to gabapentin, acetaminophen, codeine, or ibuprofen
-
Self reported renal disease (severe impaired renal function)
-
Self reported current or chronic narcotic use (typical daily use)
-
Women with any issue that, in the opinion of the investigator, would interfere with study participation or generating accurate study data
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California Davis Health System | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
- Society of Family Planning
Investigators
- Principal Investigator: Natasha Schimmoeller, MD, MPH, MA, University of California, Davis
- Study Director: Mitchell Creinin, MD, University of California, Davis
Study Documents (Full-Text)
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.
- Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. Review.
- Yan PZ, Butler PM, Kurowski D, Perloff MD. Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. Clin J Pain. 2014 Jul;30(7):613-29. doi: 10.1097/AJP.0000000000000014. Review.
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Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 61 | 60 |
COMPLETED | 60 | 58 |
NOT COMPLETED | 1 | 2 |
Baseline Characteristics
Arm/Group Title | Gabapentin | Placebo Oral Capsule | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 of all reporting groups |
Overall Participants | 60 | 58 | 118 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
25.4
(5.6)
|
27.2
(6.1)
|
26.2
(5.9)
|
Sex: Female, Male (Count of Participants) | |||
Female |
60
100%
|
58
100%
|
118
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
43
71.7%
|
42
72.4%
|
85
72%
|
Not Hispanic or Latino |
17
28.3%
|
14
24.1%
|
31
26.3%
|
Unknown or Not Reported |
0
0%
|
2
3.4%
|
2
1.7%
|
Race/Ethnicity, Customized (Count of Participants) | |||
White |
23
38.3%
|
34
58.6%
|
57
48.3%
|
Black |
11
18.3%
|
11
19%
|
22
18.6%
|
Asian |
7
11.7%
|
3
5.2%
|
10
8.5%
|
Mixed |
14
23.3%
|
5
8.6%
|
19
16.1%
|
Other |
4
6.7%
|
2
3.4%
|
6
5.1%
|
Declined |
1
1.7%
|
3
5.2%
|
4
3.4%
|
Region of Enrollment (participants) [Number] | |||
United States |
60
100%
|
58
100%
|
118
100%
|
Reasons for abortion (Count of Participants) | |||
Unwanted pregnancy |
53
88.3%
|
51
87.9%
|
104
88.1%
|
Fetal anomalies |
7
11.7%
|
7
12.1%
|
14
11.9%
|
Education (Count of Participants) | |||
Not completed high school |
6
10%
|
4
6.9%
|
10
8.5%
|
High school or equivalent |
30
50%
|
15
25.9%
|
45
38.1%
|
Some college |
16
26.7%
|
32
55.2%
|
48
40.7%
|
College or higher |
8
13.3%
|
6
10.3%
|
14
11.9%
|
Declined |
0
0%
|
1
1.7%
|
1
0.8%
|
Outcome Measures
Title | Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion |
---|---|
Description | 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. |
Time Frame | 8 hours after insertion of last osmotic dilator |
Outcome Measure Data
Analysis Population Description |
---|
Women who responded with pain scores by text using Numeric Rating Scale |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 58 | 52 |
Median (Full Range) [Numeric rating scale pain score change] |
2
|
2.5
|
Title | Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion |
---|---|
Description | 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. |
Time Frame | 5 minutes after insertion of last osmotic dilator |
Outcome Measure Data
Analysis Population Description |
---|
Women who provided Numeric rating scale pain score |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 60 | 58 |
Median (Full Range) [Numeric rating scale pain score change] |
1
|
2
|
Title | Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion |
---|---|
Description | 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. |
Time Frame | 2 hours after insertion of last osmotic dilator |
Outcome Measure Data
Analysis Population Description |
---|
Women who responded by text with numeric pain scale score |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 54 | 54 |
Median (Full Range) [Numeric rating scale pain score change] |
3.5
|
4
|
Title | Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion |
---|---|
Description | 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. |
Time Frame | 4 hours after insertion of last osmotic dilator |
Outcome Measure Data
Analysis Population Description |
---|
Women who responded by text with numeric pain scale score |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 56 | 50 |
Mean (Full Range) [Numeric rating scale pain score change] |
3
|
3.5
|
Title | Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion) |
---|---|
Description | 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. |
Time Frame | Time of presentation for D&E (day after dilator insertion) |
Outcome Measure Data
Analysis Population Description |
---|
Women who provided numeric pain scale scores |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 60 | 58 |
Median (Full Range) [Numeric rating scale pain score change] |
0.5
|
1
|
Title | Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine) |
---|---|
Description | Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion) |
Time Frame | Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure) |
Outcome Measure Data
Analysis Population Description |
---|
Any use of narcotics |
Arm/Group Title | Gabapentin | Placebo Oral Capsule |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 60 | 58 |
Count of Participants [Participants] |
35
58.3%
|
40
69%
|
Adverse Events
Time Frame | One day (from treatment initiation until procedure the following day | |||
---|---|---|---|---|
Adverse Event Reporting Description | Only adverse events collected were specific to the intervention: dizziness and tiredness | |||
Arm/Group Title | Gabapentin | Placebo Oral Capsule | ||
Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
Gabapentin | Placebo Oral Capsule | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/60 (0%) | 0/58 (0%) | ||
Serious Adverse Events |
||||
Gabapentin | Placebo Oral Capsule | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/60 (0%) | 0/58 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Gabapentin | Placebo Oral Capsule | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 57/60 (95%) | 51/58 (87.9%) | ||
General disorders | ||||
Tiredness at baseline | 7/60 (11.7%) | 7 | 4/58 (6.9%) | 4 |
Tiredness at 5 minutes after dilator placement | 7/60 (11.7%) | 7 | 12/58 (20.7%) | 12 |
Tiredness at 2 hours after dilator placement | 34/54 (63%) | 34 | 17/54 (31.5%) | 17 |
Tiredness at 4 hours after dilator placement | 37/54 (68.5%) | 37 | 18/51 (35.3%) | 18 |
Tiredness at 8 hours after dilator placement | 22/57 (38.6%) | 22 | 17/51 (33.3%) | 17 |
Tiredness at 18-24 hours after dilator placment | 18/60 (30%) | 18 | 22/58 (37.9%) | 22 |
Nervous system disorders | ||||
Dizziness at baseline | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 |
Dizziness at 5 minutes after dilator placement | 21/60 (35%) | 21 | 15/58 (25.9%) | 15 |
Dizzines at 2 hours after dilator placement | 29/53 (54.7%) | 29 | 11/53 (20.8%) | 11 |
Dizziness at 4 hours after dilator placement | 22/55 (40%) | 22 | 5/50 (10%) | 5 |
Dizziness at 8 hours after dilator placement | 15/57 (26.3%) | 15 | 3/52 (5.8%) | 3 |
Dizziness at 18-24 hours after dilator placement | 3/60 (5%) | 3 | 4/58 (6.9%) | 4 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Mitchell Creinin, MD |
---|---|
Organization | University of California, Davis |
Phone | 916-734-6670 |
mdcreinin@ucdavis.edu |
- 987072