Abstract | BACKGROUND: METHODS: The authors examined the safety and efficacy of intrathecal gabapentin in a randomized, blinded, placebo-controlled, multicenter trial in a heterogeneous cohort of candidates with chronic pain for intrathecal drug therapy. RESULTS: Patients (N = 170) were randomized to receive continuous intrathecal gabapentin (0 [placebo], 1, 6, or 30 mg/day) during 22 days of blinded treatment after implantation of a permanent drug delivery system. The highest dose, 30 mg/day, was selected to maintain a safety margin below the 100-mg/day dose that was explored in a phase 1 study. The authors found no statistically significant difference in the primary outcome measure, which was the numerical pain rating scale and response rate after 3 weeks, for any dose versus placebo. Physical functioning, quality of life, and emotional functioning also revealed no differences. Small, nonsignificant changes occurred in opioid medication use. The most frequent device-related adverse events were transient postimplant (lumbar puncture) headache, pain, and nausea. The most frequent gabapentin-related adverse events were nausea, somnolence, headache, dizziness, fatigue, and peripheral edema. CONCLUSION: Twenty-two days of intrathecal gabapentin did not demonstrate statistically significant or clinically meaningful analgesic effects. The study sponsor has no current plans for further studies. Drug-related adverse events were similar to those for oral gabapentin. Most device-related adverse events resulted from the implant surgery or anesthesia.
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Authors | Richard Rauck, Robert J Coffey, David M Schultz, Mark S Wallace, Lynn R Webster, Sally E McCarville, Eric J Grigsby, Linda M Page |
Journal | Anesthesiology
(Anesthesiology)
Vol. 119
Issue 3
Pg. 675-86
(Sep 2013)
ISSN: 1528-1175 [Electronic] United States |
PMID | 23835590
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Amines
- Analgesics
- Cyclohexanecarboxylic Acids
- gamma-Aminobutyric Acid
- Gabapentin
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Topics |
- Adult
- Aged
- Amines
(administration & dosage, adverse effects)
- Analgesics
(administration & dosage)
- Chronic Pain
(drug therapy)
- Cyclohexanecarboxylic Acids
(administration & dosage, adverse effects)
- Female
- Gabapentin
- Humans
- Injections, Spinal
- Male
- Middle Aged
- Pain, Intractable
(drug therapy)
- gamma-Aminobutyric Acid
(administration & dosage, adverse effects)
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