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Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial.

ABSTRACT: Neuropathic pain is difficult to treat, and the efficacy of recommended drugs remains limited. N-methyl-D-aspartate receptors are implicated, and antagonists are a pharmacological option. Ketamine is widely used in French pain clinics, but without consensus or recommendations. Furthermore, the association of ketamine with magnesium has been poorly studied. The aim of the present study is to evaluate the benefit of ketamine with or without magnesium in refractory neuropathic pain.A randomized, double-blind, crossover, placebo-controlled study will be performed in Clermont-Ferrand University Hospital, Clermont-Ferrand, France. The aim is to evaluate the effect of ketamine with or without magnesium in 22 patients with neuropathic pain. Intravenous ketamine/placebo, ketamine/magnesium sulfate, or placebo/placebo will be administered consecutively to each patient, in random order, once at 5-week intervals. The primary endpoint is the AUC of pain intensity assessed on a 0-10 Numeric Pain Rating Scale for a 5-week period. Data analysis will be performed on an intention-to-treat basis, and all statistical tests (except primary analysis) will be performed with an ? risk of 5% (two-sided).Considering the poor efficacy of the drugs available for neuropathic pain, ketamine with or without magnesium sulfate may be a valuable therapeutic option that needs to be standardized.EudraCT number- 2015-000142-29 . Registered on April 9, 2015; version 1.4.

SUBMITTER: Delage N

PROVIDER: S-EPMC5670712 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial.

Delage Noémie N Morel Véronique V Picard Pascale P Marcaillou Fabienne F Pereira Bruno B Pickering Gisèle G

Trials 20171103 1

<h4>Background</h4>Neuropathic pain is difficult to treat, and the efficacy of recommended drugs remains limited. N-methyl-D-aspartate receptors are implicated, and antagonists are a pharmacological option. Ketamine is widely used in French pain clinics, but without consensus or recommendations. Furthermore, the association of ketamine with magnesium has been poorly studied. The aim of the present study is to evaluate the benefit of ketamine with or without magnesium in refractory neuropathic pa ...[more]

PMID: 29100524

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Project description:BackgroundMaintenance of adequate peripheral perfusion during controlled hypotension is necessary for patient safety and improved surgical outcomes during controlled hypotension in nasal surgery. The hypothesis of this study was to investigate the effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in patients undergoing nasal surgery.MethodsA total of 50 patients were randomly assigned into two equal groups in this double-blind clinical study: the magnesium sulfate group; received 40 mg/kg loading dose of intravenous (IV) magnesium sulfate followed by 10-15 mg/kg/h continuous IV infusion and the labetalol group; received 0.25 mg/kg loading dose of IV labetalol followed by 0.5-1 mg/kg/h continuous IV infusion to achieve a mean arterial blood pressure (MABP) of = 55-65 mmHg. The primary outcome was to compare the effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion during nasal surgery. The secondary outcomes were the assessment of serum lactate, postoperative pain, time to the first call for pethidine (rescue analgesic) and total pethidine consumption.ResultsPPI was comparable between the groups at baseline, intubation, and 5 min. In contrast, magnesium sulfate group had a significantly higher PPI than the labetalol group. The magnesium sulfate group had a significantly higher MABP and heart rate compared to labetalol group. The time to reach the target MABP was significantly prolonged in magnesium sulfate than the labetalol group [21.6 ± 1.7 vs 6.9 ± 1.5] min. VAS scores were significantly lower for 2 hs postoperatively in the magnesium sulfate group than the labetalol group. The time to first call of pethidine was significantly prolonged in the magnesium sulfate group compared to the labetalol group [113.1 ± 5.2 vs 28.2 ± 1.5] min.ConclusionsMagnesium sulfate maintains wider PPI and offers better postoperative pain relief compared to labetalol during induced hypotension in nasal surgery.Trial registrationInstitutional review board approval (ref: 6601/20-12-2020).Clinicaltrialgov (ref: NCT04688203 , date of registration: 29 -12-2020).

Project description:BACKGROUND:Arterial stiffness is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. Recently, we showed that magnesium citrate supplementation results in a clinically relevant improvement of arterial stiffness. It remained unclear whether the observed effect was due to magnesium or citrate, and whether other magnesium compounds may have similar effects. Therefore, we aim to study the long-term effects of magnesium citrate, magnesium oxide and magnesium sulfate on arterial stiffness. In addition, we aim to investigate possible underlying mechanisms, including changes in blood pressure and changes in gut microbiota diversity. METHODS:In this randomized, double-blind, placebo-controlled trial, a total of 162 healthy overweight and slightly obese men and women will be recruited. During a 24-week intervention, individuals will be randomized to receive: magnesium citrate; magnesium oxide; magnesium sulfate (total daily dose of magnesium for each active treatment 450?mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid-femoral pulse wave velocity (PWVc-f), which is the gold standard for quantifying arterial stiffness. Secondary outcomes are office blood pressure, measured by a continuous blood pressure monitoring device, and gut microbiota, measured in fecal samples. Measurements will be performed at baseline and at weeks 2, 12 and 24. DISCUSSION:The present study is expected to provide evidence for the effects of different available magnesium formulations (organic and inorganic) on well-established cardiovascular risk markers, including arterial stiffness and blood pressure, as well as on the human gut microbiota. As such, the study may contribute to the primary prevention of cardiovascular disease in slightly obese, but otherwise healthy, individuals. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03632590 . Retrospectively registered on 15 August 2018.

Project description:BackgroundIndividuals with spinal cord injury (SCI) often suffer from neuropathic pain which is often disabling and negatively affects function, participation, and quality of life (QoL). Pharmacological treatments lack efficacy in neuropathic pain reduction hence studying alternatives to drug treatment is necessary. Preclinical evidence of various aerobic exercises has shown positive effects on neuropathic pain but scientific studies investigating its effect in the SCI human population are limited.MethodologyThis study is a double-blind, parallel, two-group, randomized controlled trial with an interventional study design that aims to evaluate the effectiveness of aerobic exercise program on neuropathic pain and quality of life (QoL) in individuals with chronic paraplegia. Thirty individuals with chronic paraplegia with the neurological level of injury from T2 to L2 will be recruited from the rehabilitation department at a super specialty hospital based on the inclusion criteria. Using a 1:1 allocation ratio, the participants will be randomly assigned to one of the two groups. The intervention group will perform high-intensity interval training (HIIT) aerobic exercise using an arm ergometer based on their peak heart rate, and the control group will perform free-hand arm aerobic exercise. In both groups, the intervention will be delivered as 30-min sessions, four times a week for 6 weeks.Outcome measuresInternational Spinal Cord Injury Pain Basic Data Set Version 3.0 will be used for diagnosing and assessing neuropathic pain and its interference with day-to-day activities, mood, and sleep. The International Spinal Cord Society (ISCoS) QoL basic data set will be used to assess QoL, and 6-min push test distance will be used to assess peak heart rate and aerobic capacity.DiscussionThe effectiveness of the aerobic exercise program will be assessed based on the changes in neuropathic pain score and its interference with day-to-day activities, mood, sleep, QoL, and aerobic capacity after 3 weeks mid-intervention and after 6 weeks post-intervention. The trial will provide new knowledge about the effectiveness of the aerobic exercise program in improving neuropathic pain and QoL in individuals with chronic paraplegia.Trial registrationClinical Trials Registry-India CTRI/2023/08/056257. Registered on 8 August 2023.

Project description:BackgroundChronic neuropathic pain affects 1%-2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood.MethodsAdults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events.ResultsWe recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02-1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p < 0.001; more drowsy, p = 0.003) and improved quality of sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough.ConclusionA single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long-term safety and efficacy studies are indicated. (International Standard Randomised Controlled Trial Register no. ISRCTN68314063).

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Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial.

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Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial.

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