Pregabalin vs. Gabapentin for Pain Management
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: CAMC Health System
Must be taking: Opioids
Must not be taking: Pregabalin, Gabapentin
Disqualifiers: Intubation, Epidural, Brain injury, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking pregabalin or gabapentin.
What data supports the effectiveness of the drugs gabapentin and pregabalin for pain management?
Research shows that both gabapentin and pregabalin are effective in treating neuropathic pain, with pregabalin potentially offering better tolerability and requiring fewer pills per day compared to gabapentin. Additionally, using them together may enhance pain control without significant drug interactions.
12345What safety data exists for gabapentin and pregabalin in humans?
Gabapentin and pregabalin are generally used for pain management and have been associated with some adverse drug reactions, mainly affecting the nervous system and mental health. They are considered safe for use in humans, but caution is advised, especially when used together or during pregnancy.
16789How do pregabalin and gabapentin differ in pain management?
Pregabalin may offer better tolerability and requires fewer pills per day compared to gabapentin, which can lead to a lower pill burden for patients. Additionally, pregabalin might be more effective in certain types of pain treatments and can be used in combination with gabapentin to enhance pain control without significant drug interactions.
1351011Eligibility Criteria
This trial is for adults over 18 who have been admitted to a Nurse Practitioner service with single-system orthopedic trauma, need opioids, and will stay in the hospital for more than a day. It's not for those with brain injuries, complex wounds, severe kidney issues, trouble swallowing pills, intubation, epilepsy history or substance use disorder.Inclusion Criteria
I am 18 years old or older.
I am currently prescribed opioids.
I expect to stay in the hospital for more than a day after giving consent.
+2 more
Exclusion Criteria
My kidney function is very low or I am on dialysis.
On Patient Controlled Analgesia (PCA)
I have a history of epilepsy.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications
7 days
Daily monitoring during hospital stay
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares Pregabalin (50mg) and Gabapentin (300mg) to see if they can help reduce opioid usage when given alongside standard painkillers after orthopedic trauma. Patients are randomly assigned to one of these drugs or no drug at all.
3Treatment groups
Experimental Treatment
Active Control
Group I: PregabalinExperimental Treatment1 Intervention
Group II: GabapentinExperimental Treatment1 Intervention
Group III: Neither Pregabalin nor GabapentinActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Charleston Area Medical Center"s Level 1 Trauma CenterCharleston, WV
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Who Is Running the Clinical Trial?
CAMC Health SystemLead Sponsor
References
Is there a role for combined use of gabapentin and pregabalin in pain control? Too good to be true? [2019]Gabapentin (Neurontin 1 ) and pregabalin (Lyrica 2 ) are first- and second-generation α2δ ligands, respectively, and are both approved for use as adjunctive therapy in pain control. Although they do not bind to gamma-aminobutyric acid (GABA) receptors they have been successfully used to treat neuropathic pain conditions. Their mechanism of action is not yet fully understood, but research has demonstrated promising results. Despite their similarities, they have been used in combination in both clinical and research situations, and have been noted to have a synergistic effect in pain control without concern for clinically significant pharmacokinetic interactions. This combined approach can be made use of to reduce the dose of an individual agent, its side effects, and to enhance therapeutic response compared to a single agent. Pharmacokinetics, drug interactions, and adverse reaction to combinations have to be taken into consideration before combination therapy with gabapentin and pregabalin is proposed as first-line treatment in refractory pain situations and in patients with low levels of tolerance for an individual agent.
Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. [2018]This analysis compared the therapeutic response of pregabalin in patients with neuropathic pain (NeP) who had been previously treated with gabapentin to the therapeutic response in patients who had not received gabapentin previously.
Comparing Effectiveness of Gabapentin and Pregabalin in Treatment of Neuropathic Pain: A Retrospective Cohort of Palliative Care Outpatients. [2021]Gabapentin and pregabalin are often considered first line treatment options for various neuropathic pain conditions. The purpose of this retrospective cohort study was to compare clinically meaningful pain reduction and other relevant outcomes among patients prescribed either gabapentin or pregabalin at the University of Arkansas for Medical Sciences (UAMS) Palliative Care Clinic (PCC). The primary endpoint was a significant improvement in pain within six months of initiating either gabapentin or pregabalin. Secondary endpoints included the average number of pills per day as documented at last visit in the study period, the incidence of gabapentinoid dose reductions due to adverse effects, and the incidence of discontinuation of a gabapentinoid due to adverse effects. 222 patients were included in the gabapentin group and 30 patients were included in the pregabalin group. There was not a statistically significant difference between the groups in the primary outcome of pain reduction (p = 0.43). Dose reductions due to adverse effects were statistically significantly (p = 0.03) higher in the gabapentin group than the pregabalin group. The average number of pills per day by a patient in the gabapentin group was 1.8 pills higher than the pregabalin group which was statistically significant (p = 0.01). The results of this analysis support the notion that there is no significant difference in meaningful pain reduction with gabapentin versus pregabalin. This study demonstrates that pregabalin may afford better tolerability and lower pill burden compared to gabapentin.
Substitution of gabapentin therapy with pregabalin therapy in neuropathic pain due to peripheral neuropathy. [2022]To determine the utility of substitution of pregabalin (PGB) for gabapentin (GBP) therapy in the relief of neuropathic pain (NeP) in patients with peripheral neuropathy (PN).
Relative potency of pregabalin, gabapentin, and morphine in a mouse model of visceral pain. [2018]Pregabalin is probably more effective than prototype gabapentin in different kinds of pain treatments. This study was performed to compare the potency of gabapentin, pregabalin, and morphine in a well-established model of visceral pain.
Safety of mirogabalin and pregabalin in Japanese patients with neuropathic pain: a retrospective cohort study. [2023]Few studies have compared the safety risks between the gabapentinoids, pregabalin, and mirogabalin in post-marketing clinical settings. We assessed reported events associated with gabapentinoid use in patients with neuropathic pain.
A Clinical Overview of Off-label Use of Gabapentinoid Drugs. [2020]The gabapentinoid drugs gabapentin and pregabalin were originally developed as antiseizure drugs but now are prescribed mainly for treatment of pain. For gabapentin, the only pain-related indication approved by the US Food and Drug Administration (FDA) is postherpetic neuralgia. For pregabalin, FDA-approved indications related to pain are limited to postherpetic neuralgia, neuropathic pain associated with diabetic neuropathy or spinal cord injury, and fibromyalgia. Despite these limited indications, gabapentin and pregabalin are widely prescribed off-label for various other pain syndromes. Such use is growing, possibly because clinicians are searching increasingly for alternatives to opioids.
Safety update: pregabalin during pregnancy. [2022]Overview of: Medicines and Healthcare products Regulatory Agency. Pregabalin (Lyrica): findings of safety study on risks during pregnancy. Drug Safety Update 2022;15(9):2-6.
Adverse drug reactions to gabapentin and pregabalin: a review of the French pharmacovigilance database. [2021]Gabapentin and pregabalin are widely used as antineuropathic pain drugs. Their use is also associated with the development of adverse drug reactions (ADRs), mainly neuropsychiatric.
Pregabalin and gabapentin in matched patients with peripheral neuropathic pain in routine medical practice in a primary care setting: Findings from a cost-consequences analysis in a nested case-control study. [2018]Pregabalin and gabapentin are marketed to treat peripheral neuropathic pain, but head-to-head comparison is lacking.
The Clinical Difference between Gabapentin and Pregabalin: Data from a Pilot Comparative Trial. [2021]Similar anticonvulsants, such as gabapentin and pregabalin are recommended in neuropathic pain management, however little is known about their clinical differences in cases of low back pain. This paper aims to highlight some of the possible clinical differences between gabapentin and pregabalin in low back pain.