AnalgesicsPhase 4NCT04705480
Pregabalin vs. Gabapentin on Reducing Opioid Usage
A Phase 4 study testing Pregabalin 50mg, Gabapentin 300mg and Neither Pregabalin nor Gabapentin in people with Analgesics and Gabapentin, run by CAMC Health System at 1 site in United States.
Trial summary
This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesics, Gabapentin, Injuries
- What is being tested?
- Pregabalin 50mg, Gabapentin 300mg and Neither Pregabalin nor Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 13 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurse Practitioner service admissions
- 18 years of age or older
- Patients enrolled within 36 hours of admission
- Anticipated duration of hospitalization > 24 hours from time of consent
- Active order(s) for opioids in place at the time of enrollment
Who cannot join
- Clinician discretion based on patient care management
- Intubated patients
- Patients with epidural
- Patients with pregabalin/gabapentin as home medications
- Patients receiving pregabalin/gabapentin upon admission
- Traumatic brain injury patients
Show all 12Show fewer
- CrCl<30ml/min or on HD
- Unable to take enteral medications
- On Patient Controlled Analgesia (PCA)
- Patients with complicated wound closure
- History of epilepsy
- Documented history of substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Charleston Area Medical Center"s Level 1 Trauma Center
Charleston, West Virginia, 25301
About this study
Official title: Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients
This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.
Read the detailed description
Patients included in this trial were admitted under the care of the Trauma Nurse Practitioners (TNPs) who lead management of these patients. The TNP service is a 24/7 model where TNPs admit and manage patients under the trauma attending doctors from patient arrival in the emergency department until discharge, unless a higher level of care is indicated. The TNP patient census was monitored to identify new admissions who met the study criteria. Eligibility for participation was determined based on pre-established inclusion and exclusion criteria . Over the course of the trial, three changes were made to the eligibility criteria. To increase enrollment, the inclusion age range was revised from 18-70 years to 18 years and older. Additionally, the enrollment window was adjusted from 24 hours to 36 hours to facilitate the inclusion of patients admitted over the weekend. Receipt of a peripheral nerve block was also added to the exclusion criteria due to its potential to influence reported pain levels.
Patients included in the study were divided into 3 groups: pregabalin, gabapentin, and a control group receiving neither treatment. An SPSS algorithm using simple randomization was employed to generate a randomization list and assign patients to one of three groups. A sample size of 70 patients per study group (total of 210 patients) including 10% attrition was targeted. The sample size was determined based on Cohen's d formula using a power of 80%, a medium effect size indicating a 69% difference between groups. Effect sizes were calculated for planned comparisons (pregabalin vs. gabapentin, pregabalin vs. neither pregabalin nor gabapentin, gabapentin vs. neither pregabalin nor gabapentin) using t-statistics. An interim analysis was conducted after enrollment reached approximately 25% of the projected sample size to evaluate the study progress.
Enrollment and consenting of participants were performed by the research coordinators. Upon obtaining informed consent, participants were randomized sequentially to one of the three study arms by the coordinators, using the pre-generated randomization list. Enrolled patients were informed of their study arm and the TNP's initiated study drugs accordingly. Participants were followed throughout their hospital stay and remained in the study for a duration of seven days or until discharge, whichever occurred first. Patients underwent no additional cost for participating in the study as both pregabalin and gabapentin were frequently used as adjunct analgesia in this patient population at the study institution. Standard of care remained the same regardless of study participation. Patients were removed from the study if they were transferred to a higher level of care requiring a different service line.
For dosing purposes, patients with creatinine clearance (CrCl) greater than 60 ml/min received 50 mg of pregabalin every 8 hours in the pregabalin group or 300 mg of gabapentin every 8 hours in the gabapentin group. Those with CrCl less than or equal to 60ml/min received the same dose given every 12 hours, and the regimen was changed to every 8 hours if their CrCl increased above 60ml/min while enrolled. Creatine clearance was monitored daily during hospital course with dosage adjustments as necessary.
For this study, pain scores documented by nursing staff when patients requested additional pain medications were included. Pain scores were based upon a standard Numeric Rating Scale (0 = "no pain", 10 = "worst pain imaginable"). Patients who were already using prescription narcotics were eligible to participate and were continued on their home regimens as deemed necessary by providers. Adjunct non-opioid analgesia was administered at the discretion of the managing service. In-hospital narcotic exposure was ascertained by examining total amount of narotics administered in oral Morphine Milligram Equivalents (MME).
Data were collected via patient chart review and from the institution's trauma registry. Baseline patient characteristics extracted included age, gender, body mass index (BMI), days of enrollment, time from enrollment to first study drug administration, presence of rib fracture, timestamp of surgical intervention if applicable, prescription narcotics upon admission and comorbidities. Primary outcome measures included daily opioid intake during enrollment. Secondary outcomes included daily non-opioid analgesic intake, documented pain scores, post-enrollment complications (unplanned ICU admission or intubation), and daily incentive spirometry values for those with rib fractures. Additionally, adverse events such as somnolence, dizziness, fatigue, ataxia, tremor, amnesia, etc. were also monitored.
- Conditions
- Analgesics, Gabapentin, Injuries, Narcotics, Pain, Trauma
- Being tested
- Pregabalin 50mg, Gabapentin 300mg, Neither Pregabalin nor Gabapentin
- Keywords
- Pregabalin , ,, Gabapentin, Opioid Pain Medication Use, Trauma, Opioid Usage Reduction
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 50mgDrug
Also called Lyrica
Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment).
Gabapentin 300mgDrug
Also called Neurontin
Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment).
Neither Pregabalin nor GabapentinDrug
Patients will receive neither Pregabalin nor Gabapentin.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment). Receives: Drug: Pregabalin 50mg |
| Gabapentin | Experimental | Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment). Receives: Drug: Gabapentin 300mg |
| Neither Pregabalin nor Gabapentin | Active comparator | Patients will receive neither Pregabalin nor Gabapentin Receives: Drug: Neither Pregabalin nor Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Opioid Usage
To determine if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage administered in oral Morphine Milligram Equivalents in trauma patients.
Measured: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary outcomes (5)
Difference in Initial and Last Incentive Spirometry Values
To compare the difference between the initial and last documented incentive spirometry values (mL) among patients in each of the study groups who have at least 1 rib fracture.
Measured: Initial and last incentive spirometry, with an approximate duration of 7days or discharge; if discharge < 7 days post-enrollment.
Rate of Intubation
To compare the proportion of patients requiring intubation among the study groups.
Measured: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Pain Control
To assess effectiveness of pain control in each arm based on the average Numeric Pain Rating Scale score per 24 hours. This scale is a 10 point numeric scale that ranges from 0 that represents "no pain" to 10 which indicates the "worst pain imaginable."
Measured: First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
Hospital Length of Stay
To evaluate the differences among the study arms with respect to hospital length of stay (days).
Measured: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Rate of Unplanned ICU Admission
To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.
Measured: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start12 Apr 2021
- Primary completion30 Sep 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AnalgesicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia Clinical and Translational Science Institute
- Responsible party
- Principal investigator, Nancy Payne, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705480
- Sponsor's protocol ID
- 20-718
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2021
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fabbri A, Voza A, Riccardi A, Serra S, Iaco F; Study and Research Center of the Italian Society of Emergency Medicine (SIMEU). The Pain Management of Trauma Patients in the Emergency Department. J Clin Med. 2023 May 5;12(9):3289. doi: 10.3390/jcm12093289.
PubMed 37176729Ling W, Mooney L, Hillhouse M. Prescription opioid abuse, pain and addiction: clinical issues and implications. Drug Alcohol Rev. 2011 May;30(3):300-5. doi: 10.1111/j.1465-3362.2010.00271.x.
PubMed 21545561Florence C, Luo F, Rice K. The economic burden of opioid use disorder and fatal opioid overdose in the United States, 2017. Drug Alcohol Depend. 2021 Jan 1;218:108350. doi: 10.1016/j.drugalcdep.2020.108350. Epub 2020 Oct 27.
PubMed 33121867Ramirez MF, Kamdar BB, Cata JP. Optimizing Perioperative Use of Opioids: A Multimodal Approach. Curr Anesthesiol Rep. 2020 Dec;10(4):404-415. doi: 10.1007/s40140-020-00413-6. Epub 2020 Sep 7.
PubMed 33281504Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
PubMed 30833861Ahmadi A, Bazargan-Hejazi S, Heidari Zadie Z, Euasobhon P, Ketumarn P, Karbasfrushan A, Amini-Saman J, Mohammadi R. Pain management in trauma: A review study. J Inj Violence Res. 2016 Jul;8(2):89-98. doi: 10.5249/jivr.v8i2.707. Epub 2016 Jul 7.
PubMed 27414816Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
PubMed 17513656Chin KK, Carroll I, Desai K, Asch S, Seto T, McDonald KM, Curtin C, Hernandez-Boussard T. Integrating Adjuvant Analgesics into Perioperative Pain Practice: Results from an Academic Medical Center. Pain Med. 2020 Jan 1;21(1):161-170. doi: 10.1093/pm/pnz053.
PubMed 30933284Arumugam S, Lau CS, Chamberlain RS. Use of preoperative gabapentin significantly reduces postoperative opioid consumption: a meta-analysis. J Pain Res. 2016 Sep 12;9:631-40. doi: 10.2147/JPR.S112626. eCollection 2016.
PubMed 27672340Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
PubMed 20332509Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
PubMed 29238824Campbell R, Khuong JN, Liu Z, Borg C, Jackson S, Ramson DM, Kok J, Douglas N, Penny-Dimri JC, Perry LA. Perioperative gabapentinoid use lowers short-term opioid consumption following lower limb arthroplasty: Systematic review and meta-analysis. J Opioid Manag. 2021 May-Jun;17(3):251-272. doi: 10.5055/jom.2021.0635.
PubMed 34259336Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21.
PubMed 30242745Gordh TE, Stubhaug A, Jensen TS, Arner S, Biber B, Boivie J, Mannheimer C, Kalliomaki J, Kalso E. Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. Pain. 2008 Aug 31;138(2):255-266. doi: 10.1016/j.pain.2007.12.011. Epub 2008 Feb 6.
PubMed 18258368Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007076. doi: 10.1002/14651858.CD007076.pub2.
PubMed 19588419
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients
- ClinicalTrials.gov ID
- NCT04705480
- Acronym / sponsor ID
- 20-718
- Conditions
- Analgesics, Gabapentin, Injuries, Narcotics, Pain, Trauma
- Keywords
- Pregabalin , ,, Gabapentin, Opioid Pain Medication Use, Trauma, Opioid Usage Reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Collaborators
- West Virginia Clinical and Translational Science Institute
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.
Detailed description
Patients included in this trial were admitted under the care of the Trauma Nurse Practitioners (TNPs) who lead management of these patients. The TNP service is a 24/7 model where TNPs admit and manage patients under the trauma attending doctors from patient arrival in the emergency department until discharge, unless a higher level of care is indicated. The TNP patient census was monitored to identify new admissions who met the study criteria. Eligibility for participation was determined based on pre-established inclusion and exclusion criteria . Over the course of the trial, three changes were made to the eligibility criteria. To increase enrollment, the inclusion age range was revised from 18-70 years to 18 years and older. Additionally, the enrollment window was adjusted from 24 hours to 36 hours to facilitate the inclusion of patients admitted over the weekend. Receipt of a peripheral nerve block was also added to the exclusion criteria due to its potential to influence reported pain levels.
Patients included in the study were divided into 3 groups: pregabalin, gabapentin, and a control group receiving neither treatment. An SPSS algorithm using simple randomization was employed to generate a randomization list and assign patients to one of three groups. A sample size of 70 patients per study group (total of 210 patients) including 10% attrition was targeted. The sample size was determined based on Cohen's d formula using a power of 80%, a medium effect size indicating a 69% difference between groups. Effect sizes were calculated for planned comparisons (pregabalin vs. gabapentin, pregabalin vs. neither pregabalin nor gabapentin, gabapentin vs. neither pregabalin nor gabapentin) using t-statistics. An interim analysis was conducted after enrollment reached approximately 25% of the projected sample size to evaluate the study progress.
Enrollment and consenting of participants were performed by the research coordinators. Upon obtaining informed consent, participants were randomized sequentially to one of the three study arms by the coordinators, using the pre-generated randomization list. Enrolled patients were informed of their study arm and the TNP's initiated study drugs accordingly. Participants were followed throughout their hospital stay and remained in the study for a duration of seven days or until discharge, whichever occurred first. Patients underwent no additional cost for participating in the study as both pregabalin and gabapentin were frequently used as adjunct analgesia in this patient population at the study institution. Standard of care remained the same regardless of study participation. Patients were removed from the study if they were transferred to a higher level of care requiring a different service line.
For dosing purposes, patients with creatinine clearance (CrCl) greater than 60 ml/min received 50 mg of pregabalin every 8 hours in the pregabalin group or 300 mg of gabapentin every 8 hours in the gabapentin group. Those with CrCl less than or equal to 60ml/min received the same dose given every 12 hours, and the regimen was changed to every 8 hours if their CrCl increased above 60ml/min while enrolled. Creatine clearance was monitored daily during hospital course with dosage adjustments as necessary.
For this study, pain scores documented by nursing staff when patients requested additional pain medications were included. Pain scores were based upon a standard Numeric Rating Scale (0 = "no pain", 10 = "worst pain imaginable"). Patients who were already using prescription narcotics were eligible to participate and were continued on their home regimens as deemed necessary by providers. Adjunct non-opioid analgesia was administered at the discretion of the managing service. In-hospital narcotic exposure was ascertained by examining total amount of narotics administered in oral Morphine Milligram Equivalents (MME).
Data were collected via patient chart review and from the institution's trauma registry. Baseline patient characteristics extracted included age, gender, body mass index (BMI), days of enrollment, time from enrollment to first study drug administration, presence of rib fracture, timestamp of surgical intervention if applicable, prescription narcotics upon admission and comorbidities. Primary outcome measures included daily opioid intake during enrollment. Secondary outcomes included daily non-opioid analgesic intake, documented pain scores, post-enrollment complications (unplanned ICU admission or intubation), and daily incentive spirometry values for those with rib fractures. Additionally, adverse events such as somnolence, dizziness, fatigue, ataxia, tremor, amnesia, etc. were also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin 50mgPatients will receive 50 mg every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment). |
| Gabapentin | Experimental | Drug: Gabapentin 300mgPatients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment). |
| Neither Pregabalin nor Gabapentin | Active comparator | Drug: Neither Pregabalin nor GabapentinPatients will receive neither Pregabalin nor Gabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nurse Practitioner service admissions
- 18 years of age or older
- Patients enrolled within 36 hours of admission
- Anticipated duration of hospitalization > 24 hours from time of consent
- Active order(s) for opioids in place at the time of enrollment
Key exclusion criteria (12 listed)
- Clinician discretion based on patient care management
- Intubated patients
- Patients with epidural
- Patients with pregabalin/gabapentin as home medications
- Patients receiving pregabalin/gabapentin upon admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 50mgAlso: LyricaPatients will receive 50 mg every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment). | Drug | Pregabalin |
| Gabapentin 300mgAlso: NeurontinPatients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment). | Drug | Gabapentin |
| Neither Pregabalin nor GabapentinPatients will receive neither Pregabalin nor Gabapentin. | Drug | Neither Pregabalin nor Gabapentin |
Primary outcome
Reduction in Opioid Usage
Time frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
To determine if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage administered in oral Morphine Milligram Equivalents in trauma patients.
5 secondary outcomes
Difference in Initial and Last Incentive Spirometry Values
Time frame: Initial and last incentive spirometry, with an approximate duration of 7days or discharge; if discharge < 7 days post-enrollment.
Rate of Intubation
Time frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Pain Control
Time frame: First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
Hospital Length of Stay
Time frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Rate of Unplanned ICU Admission
Time frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37176729Fabbri A, Voza A, Riccardi A, Serra S, Iaco F; Study and Research Center of the Italian Society of Emergency Medicine (SIMEU). The Pain Management of Trauma Patients in the Emergency Department. J Clin Med. 2023 May 5;12(9):3289. doi: 10.3390/jcm12093289.
- Background: PubMed 21545561Ling W, Mooney L, Hillhouse M. Prescription opioid abuse, pain and addiction: clinical issues and implications. Drug Alcohol Rev. 2011 May;30(3):300-5. doi: 10.1111/j.1465-3362.2010.00271.x.
- Background: PubMed 33121867Florence C, Luo F, Rice K. The economic burden of opioid use disorder and fatal opioid overdose in the United States, 2017. Drug Alcohol Depend. 2021 Jan 1;218:108350. doi: 10.1016/j.drugalcdep.2020.108350. Epub 2020 Oct 27.
- Background: PubMed 33281504Ramirez MF, Kamdar BB, Cata JP. Optimizing Perioperative Use of Opioids: A Multimodal Approach. Curr Anesthesiol Rep. 2020 Dec;10(4):404-415. doi: 10.1007/s40140-020-00413-6. Epub 2020 Sep 7.
- Background: PubMed 30833861Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
- Background: PubMed 27414816Ahmadi A, Bazargan-Hejazi S, Heidari Zadie Z, Euasobhon P, Ketumarn P, Karbasfrushan A, Amini-Saman J, Mohammadi R. Pain management in trauma: A review study. J Inj Violence Res. 2016 Jul;8(2):89-98. doi: 10.5249/jivr.v8i2.707. Epub 2016 Jul 7.
- Background: PubMed 17513656Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
- Background: PubMed 30933284Chin KK, Carroll I, Desai K, Asch S, Seto T, McDonald KM, Curtin C, Hernandez-Boussard T. Integrating Adjuvant Analgesics into Perioperative Pain Practice: Results from an Academic Medical Center. Pain Med. 2020 Jan 1;21(1):161-170. doi: 10.1093/pm/pnz053.
- Background: PubMed 27672340Arumugam S, Lau CS, Chamberlain RS. Use of preoperative gabapentin significantly reduces postoperative opioid consumption: a meta-analysis. J Pain Res. 2016 Sep 12;9:631-40. doi: 10.2147/JPR.S112626. eCollection 2016.
- Background: PubMed 20332509Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- Background: PubMed 29238824Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
- Background: PubMed 34259336Campbell R, Khuong JN, Liu Z, Borg C, Jackson S, Ramson DM, Kok J, Douglas N, Penny-Dimri JC, Perry LA. Perioperative gabapentinoid use lowers short-term opioid consumption following lower limb arthroplasty: Systematic review and meta-analysis. J Opioid Manag. 2021 May-Jun;17(3):251-272. doi: 10.5055/jom.2021.0635.
- Center for Disease Control and Prevention. Drug overdose mortality by state. Center for Disease Control and Prevention. Published 2022.Link provided by the sponsor.
- American College of Surgeons. ACS Trauma Quality Programs Best Practices Guidelines for Acute Pain Management in Trauma Patients.; 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 50mg, Gabapentin 300mg and Neither Pregabalin nor Gabapentin in people with Analgesics and Gabapentin, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Opioid Usage (time frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705480, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.