Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial

NCT03080493 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 987072
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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:

1. 1.Women's pain experience with dilators in their cervix overnight before the abortion procedure
2. 2.How well gabapentin works to decrease women's pain while they have the dilators in their cervix

Conditions

Abortion, Induced; Cervical Preparation; Pain

Keywords

Abortion; Osmotic dilators; Gabapentin; Text message

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in NRS Pain Score at 8 Hours 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 via text message.

  8 hours after insertion of last osmotic dilator

Secondary Outcomes (5)

• Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion

  5 minutes after insertion of last osmotic dilator

• Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion

  2 hours after insertion of last osmotic dilator

• Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion

  4 hours after insertion of last osmotic dilator

• 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)

• 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)

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

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; Drug: acetaminophen/codeine and ibuprofen

Placebo oral capsule

PLACEBO COMPARATOR

Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight

Drug: Placebo oral capsule; Drug: acetaminophen/codeine and ibuprofen

Interventions

Gabapentin 600mg DRUG

Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)

Also known as: Neurontin

Gabapentin

Placebo oral capsule DRUG

Packaged identical to gabapentin dosing

Also known as: Carboxymethyl cellulose

Placebo oral capsule

acetaminophen/codeine and ibuprofen DRUG

Over the counter analgesic medications

Also known as: Tylenol-Codeine No. 3, Advil

Gabapentin; Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of California Davis Health System

Sacramento, California, 95817, United States

Location

Related Publications (3)

• 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.

  PMID: 24281281 BACKGROUND

• Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. doi: 10.1046/j.0003-2409.2001.02399.x.

  PMID: 11966555 BACKGROUND

• 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.

  PMID: 25139724 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Gabapentin; Carboxymethylcellulose Sodium; Acetaminophen; Codeine; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates; Acetanilides; Anilides; Amides; Aniline Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates

Results Point of Contact

• Title: Mitchell Creinin, MD
• Organization: University of California, Davis

mdcreinin@ucdavis.edu

916-734-6670

Study Officials

• Natasha Schimmoeller, MD, MPH, MA

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Mitchell Creinin, MD

  University of California, Davis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized placebo controlled trial, stratified block randomization based on prior vaginal parity (vaginal parity - yes or no). Goal of even distribution of prior vaginal parity between gabapentin and placebo groups as may impact osmotic dilator pain experience

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: March 20, 2017
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: April 14, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)