Pregabalin vs. Gabapentin for Pain Management

Overseen By John A DeLuca, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: CAMC Health System

Must be taking: Opioids

Must not be taking: Pregabalin, Gabapentin

Disqualifiers: Intubation, Epidural, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

210 Participants Needed

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. ^{1 2 3 4 5}

What 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. ^{1 6 7 8 9}

How 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. ^{1 3 5 10 11}

Eligibility 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.

Exclusion Criteria

My kidney function is very low or I am on dialysis.

On Patient Controlled Analgesia (PCA)

I have a history of epilepsy.

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

Treatment Details

Interventions

• Gabapentin
• Pregabalin

Trial Overview 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.

Participant Groups

Group I: Pregabalin Experimental Treatment 1 Intervention

Group II: Gabapentin Experimental Treatment 1 Intervention

Group III: Neither Pregabalin nor Gabapentin Active Control 1 Intervention

Who Is Running the Clinical Trial?

CAMC Health System

Lead Sponsor

Trials

47

Recruited

8,000+

Findings from Research

Gabapentin and pregabalin, both used for neuropathic pain, can be combined effectively without significant drug interactions, potentially enhancing pain control while allowing for lower doses of each medication.

This combination therapy may help reduce side effects and improve therapeutic responses, but careful consideration of pharmacokinetics and patient tolerance is necessary before recommending it as a first-line treatment for difficult pain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for combined use of gabapentin and pregabalin in pain control? Too good to be true? Senderovich, H., Jeyapragasan, G.[2019]

In a review of 18 randomized trials involving patients with neuropathic pain, pregabalin showed similar effectiveness in pain relief and sleep interference, regardless of whether patients had previously been treated with gabapentin.

The study suggests that pregabalin can be a suitable treatment option for patients who did not respond well to gabapentin, indicating the importance of personalized treatment strategies for neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Markman, JD., Jensen, TS., Semel, D., et al.[2018]

In a study of 252 patients, gabapentin and pregabalin showed no significant difference in pain reduction after six months, indicating both are similarly effective for neuropathic pain.

However, pregabalin was associated with fewer dose reductions due to side effects and required fewer pills per day compared to gabapentin, suggesting it may be better tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Effectiveness of Gabapentin and Pregabalin in Treatment of Neuropathic Pain: A Retrospective Cohort of Palliative Care Outpatients. Dragic, L., Webb, T., Chandler, M., et al.[2021]

Substituting pregabalin (PGB) for gabapentin (GBP) in patients with peripheral neuropathy resulted in an additional 25% relief of neuropathic pain after 6 and 12 months, indicating PGB may be more effective for some patients.

While there were no serious adverse events reported, over 30% of GBP nonresponders discontinued PGB due to inefficacy or side effects, highlighting the need for careful monitoring when switching medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substitution of gabapentin therapy with pregabalin therapy in neuropathic pain due to peripheral neuropathy. Toth, C.[2022]

Pregabalin is significantly more potent than gabapentin in treating visceral pain, with an effective dose (ED50) of 17.1 mg/kg compared to gabapentin's 87.1 mg/kg, indicating it may be a more effective option for pain management.

While pregabalin is more effective than gabapentin, it is still much less potent than morphine, which has an ED50 of only 0.2 mg/kg, suggesting that while pregabalin is a strong analgesic, morphine remains the most powerful option in this model of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative potency of pregabalin, gabapentin, and morphine in a mouse model of visceral pain. Shamsi Meymandi, M., Keyhanfar, F.[2018]

In a study of 3,894 patients (1,650 new users of mirogabalin and 2,244 new users of pregabalin), no serious safety concerns were identified for either medication in treating neuropathic pain.

However, mirogabalin users showed a higher hazard ratio for several common adverse events, such as nausea (2.8) and edema (3.1), suggesting a potentially increased risk compared to pregabalin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mirogabalin and pregabalin in Japanese patients with neuropathic pain: a retrospective cohort study. Nakajima, R., Ooba, N., Kamei, M., et al.[2023]

Gabapentin and pregabalin, originally developed for seizures, are now mainly used for pain management, but their FDA-approved uses for pain are quite limited, primarily to specific conditions like postherpetic neuralgia and fibromyalgia.

There is limited evidence supporting the off-label use of gabapentinoids for various pain syndromes, and clinicians should inform patients about the uncertainty of benefits when prescribing these medications for unapproved uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Overview of Off-label Use of Gabapentinoid Drugs. Goodman, CW., Brett, AS.[2020]

A safety study conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) evaluated the risks associated with the use of pregabalin (Lyrica) during pregnancy, highlighting potential safety concerns for pregnant individuals.

The findings emphasize the importance of careful consideration and monitoring when prescribing pregabalin to pregnant patients, as the study aims to inform healthcare providers about the risks involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: pregabalin during pregnancy. [2022]

A total of 1333 adverse drug reactions (ADRs) were reported for gabapentin and pregabalin, with a significant prevalence of neuropsychiatric ADRs, highlighting the need for careful monitoring of these medications.

The study identified serious concerns, including 22 deaths associated with these drugs, particularly noting 8 deaths related to gabapentin in obstetrical situations, and new ADRs such as hepatitis linked to gabapentin and hematological issues with pregabalin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to gabapentin and pregabalin: a review of the French pharmacovigilance database. Fuzier, R., Serres, I., Guitton, E., et al.[2021]

In a study comparing 44 patients on gabapentin and 88 on pregabalin for chronic peripheral neuropathic pain, pregabalin showed a greater reduction in pain intensity and a higher percentage of patients achieving significant pain relief (60.9% vs 40.5%).

Despite the higher cost of pregabalin, the overall costs related to productivity losses were similar between the two medications, indicating that pregabalin may provide better pain relief without increasing overall treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Pérez, C., Navarro, A., Saldaña, MT., et al.[2018]

In a study of 64 patients with moderate to severe low back pain, pregabalin (300 mg/day) was found to significantly reduce pain intensity compared to gabapentin (800 mg/day), indicating its potential superiority in pain management.

Gabapentin showed greater improvements in secondary symptoms such as anxiety, insomnia, and fatigue compared to pregabalin, suggesting that while pregabalin is better for pain relief, gabapentin may be more beneficial for overall well-being in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Difference between Gabapentin and Pregabalin: Data from a Pilot Comparative Trial. Gammoh, O., Al-Smadi, A., Shawagfeh, MQ., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Is there a role for combined use of gabapentin and pregabalin in pain control? Too good to be true? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Comparing Effectiveness of Gabapentin and Pregabalin in Treatment of Neuropathic Pain: A Retrospective Cohort of Palliative Care Outpatients. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Substitution of gabapentin therapy with pregabalin therapy in neuropathic pain due to peripheral neuropathy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Relative potency of pregabalin, gabapentin, and morphine in a mouse model of visceral pain. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Safety of mirogabalin and pregabalin in Japanese patients with neuropathic pain: a retrospective cohort study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Clinical Overview of Off-label Use of Gabapentinoid Drugs. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Safety update: pregabalin during pregnancy. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to gabapentin and pregabalin: a review of the French pharmacovigilance database. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

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]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Clinical Difference between Gabapentin and Pregabalin: Data from a Pilot Comparative Trial. [2021]