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Medicine Dec 2021In 2013, the U.S. Food and Drug Administration issued a safety warning that cautioned against using magnesium sulfate (MgSO4) injections for more than 5 to 7 days to...
In 2013, the U.S. Food and Drug Administration issued a safety warning that cautioned against using magnesium sulfate (MgSO4) injections for more than 5 to 7 days to stop preterm delivery due to the bone problems subsequently observed in infants. However, the warning was mainly based on case reports, and further investigation is necessary to determine whether prolonged MgSO4 use increased infant fractures.To evaluate whether prolonged MgSO4 use for tocolysis increased the risk of subsequent fractures among infants.A retrospective population-based cohort study was conducted with a new-user study design using the National Health Insurance Database in Taiwan. We included pregnant women aged between 12 and 55 years old who delivered a live-born singleton. The enrollment period was from January 1, 2012 to December 31, 2014. The exposure group was defined as pregnant women who received MgSO4 injection for >5 days during pregnancy, while those not receiving any tocolytics were the reference group. The outcome was any bone fracture among the infants during the 2-year follow-up period. Propensity score matching and Cox proportional hazards regression models were used to estimate the hazard of fractures. We further studied the effect of MgSO4 treatment with varied dosages and durations of treatment in the sensitivity analyses.Among the 4092 pregnant women in the database, 693 (16.9%) of them were included in the exposure group. The hazard ratio of infant fractures among prolonged MgSO4 users was not significantly different from that of tocolytic nonusers in adjusted models (adjusted hazard ratio (aHR) = 1.48; 95% confidence interval (CI) = 0.59-3.71). A similar lack of significance was found in the sensitivity analyses (aHR = 1.45; 95% CI = 0.40-5.28 for larger treatment dosage; aHR = 2.52; 95% CI = 0.49-12.98 for longer treatment duration).Prolonged MgSO4 tocolysis use did not increase the risk of infant fractures. Our findings reconfirmed the safety of MgSO4 as a tocolytic treatment.
Topics: Adolescent; Adult; Child; Cohort Studies; Female; Fractures, Bone; Humans; Infant; Infant, Newborn; Magnesium Sulfate; Middle Aged; Pregnancy; Retrospective Studies; Tocolysis; Tocolytic Agents; Young Adult
PubMed: 34941123
DOI: 10.1097/MD.0000000000028310 -
Scientific Reports Feb 2019Magnesium sulfate can be used as a co-adjuvant drug during the perioperative period and has multiple benefits. Recent evidence suggested that perioperative magnesium...
Retrospective analysis of the association between intraoperative magnesium sulfate infusion and postoperative acute kidney injury after major laparoscopic abdominal surgery.
Magnesium sulfate can be used as a co-adjuvant drug during the perioperative period and has multiple benefits. Recent evidence suggested that perioperative magnesium sulfate infusion may lower the risk of postoperative acute kidney injury (AKI). We investigated the association between intraoperative magnesium sulfate infusion and incidence of AKI after major laparoscopic abdominal surgery. We retrospectively analyzed the medical records of adult patients 20 years or older who underwent elective major laparoscopic abdominal surgery (>2 hours) between 2010 and 2016. We investigated the association between intraoperative magnesium sulfate infusion and the incidence of postoperative AKI until postoperative day (POD) 3 using a multivariable logistic regression analysis. We included 3,828 patients in this analysis; 357 patients (9.3%) received an intraoperative magnesium sulfate infusion and 186 patients (4.9%) developed postoperative AKI by POD 3. A multivariable logistic regression analysis showed that magnesium infusion was associated with a significant decrease (63%) in postoperative AKI (odds ratio, 0.37; 95% confidence interval, 0.14-0.94; P = 0.037). Our study suggested that intraoperative magnesium sulfate infusion is associated with a reduced risk of postoperative AKI until POD 3 for patients who underwent laparoscopic major abdominal surgery. Well-designed, prospective studies should be conducted to further substantiate these findings.
Topics: Abdomen; Acute Kidney Injury; Cohort Studies; Female; Humans; Laparoscopy; Magnesium Sulfate; Male; Middle Aged; Perioperative Period; Postoperative Complications; Retrospective Studies; Risk
PubMed: 30808887
DOI: 10.1038/s41598-019-39106-4 -
Turkish Neurosurgery 2013It is well known that head trauma results in damage in hippocampal and cortical areas of the brain and impairs cognitive functions. The aim of this study is to explore...
AIM
It is well known that head trauma results in damage in hippocampal and cortical areas of the brain and impairs cognitive functions. The aim of this study is to explore the neuroprotective effect of combination therapy with magnesium sulphate (MgSO4) and progesterone in the 7-days-old rat pups subjected to contusion injury.
MATERIAL AND METHODS
Progesterone (8 mg/kg) and MgSO4 (150 mg/kg) were injected intraperitoneally immediately after induction of traumatic brain injury. Half of groups were evaluated 24 hours later, the remaining animals 3 weeks after trauma or sham surgery. Anxiety levels were assessed with open field activity and elevated plus maze; learning and memory performance were evaluated with Morris Water maze in postnatal 27 days.
RESULTS
Combined therapy with progesterone and magnesium sulfate significantly attenuated trauma-induced neuronal death, increased brain VEGF levels and improved spatial memory deficits that appear later in life. Brain VEGF levels were higher in rats that received combined therapy compared to rats that received either medication alone. Moreover, rats that received combined therapy had reduced hipocampus and prefrontal cortex apoptosis in the acute period.
CONCLUSION
These results demonstrate that combination of drugs with different mechanisms of action may be preferred in the treatment of head trauma.
Topics: Animals; Anxiety; Apoptosis; Brain; Brain Injuries; DNA Fragmentation; Magnesium Sulfate; Maze Learning; Memory; Neuroprotective Agents; Progesterone; Rats; Rats, Wistar
PubMed: 23546895
DOI: 10.5137/1019-5149.JTN.5582-11.1 -
BMC Infectious Diseases Aug 2019Brainstem encephalitis is a serious complication of hand foot and mouth disease (HFMD) in children. Autonomic nervous system (ANS) dysregulation and hypertension may... (Observational Study)
Observational Study Randomized Controlled Trial
Assessing the efficacy and safety of magnesium sulfate for management of autonomic nervous system dysregulation in Vietnamese children with severe hand foot and mouth disease.
BACKGROUND
Brainstem encephalitis is a serious complication of hand foot and mouth disease (HFMD) in children. Autonomic nervous system (ANS) dysregulation and hypertension may occur, sometimes progressing to cardiopulmonary failure and death. Vietnamese national guidelines recommend use of milrinone if ANS dysregulation with Stage 2 hypertension develops. We wished to investigate whether magnesium sulfate (MgSO) improved outcomes in children with HFMD if used earlier in the evolution of the ANS dysregulation (Stage 1 hypertension).
METHODS
During a regional epidemic we conducted a randomized, double-blind, placebo-controlled trial of MgSO in children with HFMD, ANS dysregulation and Stage 1 hypertension, at the Hospital for Tropical Diseases in Ho Chi Minh city. Study participants received an infusion of MgSO or matched placebo for 72 h. We also reviewed data from non-trial HFMD patients in whom milrinone failed to control hypertension, some of whom received MgSO as second line therapy. The primary outcome for both analyses was a composite of disease progression within 72 h - addition of milrinone (trial participants only), need for ventilation, shock, or death.
RESULTS
Between June 2014 and September 2016, 14 and 12 participants received MgSO or placebo respectively, before the trial was stopped due to futility. Among 45 non-trial cases with poorly controlled hypertension despite high-dose milrinone, 33 received MgSO while 12 did not. There were no statistically significant differences in the composite outcome between the MgSO and the placebo/control groups in either study (adjusted relative risk (95%CI) of [6/14 (43%) vs. 6/12 (50%)], 0.84 (0.37, 1.92), p = 0.682 in the trial and [1/33 (3%) vs. 2/12 (17%)], 0.16 (0.01, 1.79), p = 0.132 in the observational cohort). The incidence of adverse events was similar between the groups. Potentially toxic magnesium levels occurred very rarely with the infusion regime used.
CONCLUSION
Although we could not demonstrate efficacy in these studies, there were no safety signals associated with use of 30-50 mg/kg/hr. MgSO in severe HFMD. Intermittent outbreaks of HFMD are likely to continue across the region, and an adequately powered trial is still needed to evaluate use of MgSO in controlling hypertension in severe HFMD, potentially involving a higher dose regimen.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01940250 (Registered 22 AUG 2013). Trial sponsor: University of Oxford.
Topics: Animals; Autonomic Nervous System; Autonomic Nervous System Diseases; Child; Child, Preschool; Cohort Studies; Disease Progression; Double-Blind Method; Female; Hand, Foot and Mouth Disease; Hemodynamics; Humans; Infant; Magnesium Sulfate; Male; Placebos
PubMed: 31438878
DOI: 10.1186/s12879-019-4356-x -
BMJ Paediatrics Open May 2024To review the efficacy of nebulised magnesium sulfate (MgSO) in acute asthma in children. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To review the efficacy of nebulised magnesium sulfate (MgSO) in acute asthma in children.
METHODS
The authors searched Medline, Embase, Web of Science and Cochrane Library for randomised controlled trials (RCTs) published until 15 December 2023. RCTs were included if they compared the efficacy and safety of nebulised MgSO as a second-line agent in children presenting with acute asthma exacerbation. A random-effects meta-analysis was performed, and the Risk of Bias V.2 tool was used to assess the biases among them.
RESULTS
10 RCTs enrolling 2301 children with acute asthma were included. All trials were placebo controlled and administered nebulised MgSO/placebo and salbutamol (±ipratropium bromide). There was no significant difference in Composite Asthma Severity Score between the two groups (6 RCTs, 1953 participants; standardised mean difference: -0.09; 95% CI: -0.2 to +0.02, I=21%). Children in the MgSO group have significantly better peak expiratory flow rate (% predicted) than the control group (2 RCTs, 145 participants; mean difference: 19.3; 95% CI: 8.9 to 29.8; I=0%). There was no difference in the need for hospitalisation, intensive care unit admission or duration of hospital stay. Adverse events were minor, infrequent (7.3%) and similar among the two groups.
CONCLUSIONS
There is low-certainty evidence that nebulised MgSO as an add-on second-line therapy for acute asthma in children does not reduce asthma severity or a need for hospitalisation. However, it was associated with slightly better lung functions. The current evidence does not support the routine use of nebulised MgSO in paediatric acute asthma management.
PROSPERO REGISTRATION NUMBER
CRD42022373692.
Topics: Humans; Magnesium Sulfate; Asthma; Child; Nebulizers and Vaporizers; Acute Disease; Administration, Inhalation; Bronchodilator Agents; Randomized Controlled Trials as Topic; Anti-Asthmatic Agents
PubMed: 38782483
DOI: 10.1136/bmjpo-2024-002638 -
Journal of Healthcare Engineering 2022The incidence of pregnancy-induced hypertension in China is 9.4%, which is at a relatively high level. Its serious impact on maternal and infant health is the main... (Randomized Controlled Trial)
Randomized Controlled Trial
The incidence of pregnancy-induced hypertension in China is 9.4%, which is at a relatively high level. Its serious impact on maternal and infant health is the main reason for maternal and perinatal morbidity and mortality. There are many factors affecting pregnancy-induced hypertension. The incidence of pregnancy-induced hypertension is different due to different levels of cultural knowledge, health awareness, economic income, nutrition, and medical support. Since its etiology has not been elucidated thus far, there is no known treatment of the disease, and the main principles are spasmolysis, hypotension, expansion, and timely termination of pregnancy. Observe the effect of nimodipine combined with magnesium sulfate on serum heat shock protein 70 (HSP70) and pentamer 3 (PTX3) levels in patients with pregnancy-induced hypertension. Ninety-six patients with pregnancy-induced hypertension syndrome admitted to our hospital from May 2016 to February 2019 are selected and randomly divided into two groups according to the 1 : 1 principle, with 48 cases in each group. The single drug group is treated with magnesium sulfate, and the combined group is treated with nimodipine combined with magnesium sulfate. Changes in blood pressure, HSP70, PTX3, placental growth factor (PLGF), and vascular endothelial cell injury markers are recorded in the two groups, and adverse reactions and pregnancy outcomes are observed. After treatment, the blood pressure and levels of HSP70, PTX3, endothelin-1 (ET-1), and nitric oxide (NO) in the two groups decreased, and the level of PLGF increased. The diastolic blood pressure, systolic blood pressure, and levels of HSP70, PTX3, ET-1, and NO in the combined group are lower than those in the single drug group, and the level of PLGF is higher than that in the single drug group ( < 0.05). During the treatment period, the adverse reaction rate of the combined group is 6.25% compared with 8.33% of the single agent group, and the difference is not statistically significant ( > 0.05). Follow-up visits found that the cesarean section rate and abnormal fetal heart rate in the combined group are 16.67% and 4.17%, respectively, which are lower than 35.42% and 16.67% in the single drug group, and the difference is statistically significant ( < 0.05). Compared with 14.58%, 12.50%, and 2.08% in the single drug group, the neonatal asphyxia rate, premature birth rate, and stillbirth rate in the combined group are 6.25%, 4.17%, and 0.00%, respectively, and the difference is not statistically significant ( > 0.05). Nimodipine combined with magnesium sulfate can effectively control blood pressure in patients with pregnancy-induced hypertension, reduce vascular endothelial damage, regulate the expression of HSP70, PTX3, and PLGF, and improve pregnancy outcomes without increasing adverse reactions.
Topics: Cesarean Section; Female; Humans; Hypertension, Pregnancy-Induced; Infant, Newborn; Magnesium Sulfate; Nimodipine; Placenta Growth Factor; Pregnancy
PubMed: 35368954
DOI: 10.1155/2022/7217543 -
Ketamine and Magnesium for Refractory Neuropathic Pain: A Randomized, Double-blind, Crossover Trial.Anesthesiology Jul 2020Ketamine is often used for the management of refractory chronic pain. There is, however, a paucity of trials exploring its analgesic effect several weeks after... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Ketamine is often used for the management of refractory chronic pain. There is, however, a paucity of trials exploring its analgesic effect several weeks after intravenous administration or in association with magnesium. The authors hypothesized that ketamine in neuropathic pain may provide pain relief and cognitive-emotional benefit versus placebo and that a combination with magnesium may have an additive effect for 5 weeks.
METHODS
A randomized, double-blind, crossover, placebo-controlled study (NCT02467517) included 20 patients with neuropathic pain. Each ketamine-naïve patient received one infusion every 35 days in a random order: ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo.The primary endpoint was the area under the curve of daily pain intensity for a period of 35 days after infusion. Secondary endpoints included pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires.
RESULTS
Daily pain intensity was not significantly different between the three groups (n = 20) over 35 days (mean area under the curve = 185 ± 100, 196 ± 92, and 187 ± 90 pain score-days for ketamine, ketamine/magnesium, and placebo, respectively, P = 0.296). The effect size of the main endpoint was -0.2 (95% CI [-0.6 to 0.3]; P = 0.425) for ketamine versus placebo, 0.2 (95% CI [-0.3 to 0.6]; P = 0.445) for placebo versus ketamine/magnesium and -0.4 (95% CI [-0.8 to 0.1]; P = 0.119) for ketamine versus ketamine/magnesium. There were no significant differences in emotional, sleep, and quality of life measures. During placebo, ketamine, and ketamine/magnesium infusions, 10%, 20%, and 35% of patients respectively reported at least one adverse event.
CONCLUSIONS
The results of this trial in neuropathic pain refuted the hypothesis that ketamine provided pain relief at 5 weeks and cognitive-emotional benefit versus placebo and that a combination with magnesium had any additional analgesic effect.
Topics: Adult; Aged; Cognition; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Emotions; Excitatory Amino Acid Antagonists; Female; Humans; Infusions, Intravenous; Ketamine; Magnesium Sulfate; Male; Middle Aged; Neuralgia; Pain Measurement; Treatment Outcome
PubMed: 32384291
DOI: 10.1097/ALN.0000000000003345 -
American Journal of Health-system... Apr 2010The physical compatibility of magnesium sulfate and sodium bicarbonate in a pharmacy-compounded hemofiltration solution was assessed.
PURPOSE
The physical compatibility of magnesium sulfate and sodium bicarbonate in a pharmacy-compounded hemofiltration solution was assessed.
METHODS
Two bicarbonate-buffered hemofiltration solutions (low- and high-magnesium formulations) were compounded in triplicate. The concentrations of magnesium (15 meq/L) and sodium bicarbonate (50 meq/L) in the high-magnesium formulation were chosen to be somewhat below the concentrations reported as being incompatible in a popular reference. The six hemofiltration bags were stored at 22-25 degrees C without protection from light for 48 hours. Physical compatibility was assessed by visual inspection and microscopy. The pH of the solutions was assayed 3-4 and 52-53 hours after compounding. Electrolyte and glucose concentrations of the solutions were assayed at 3-4 and 50-51 hours after preparation.
RESULTS
No particulate matter was observed by visual or microscopic inspection in the compounded hemofiltration solutions at 48 hours. The mean +/- S.D. pH values of the low-magnesium solutions were 8.01 +/- 0.02 and 8.04 +/- 0.02 at 3-4 and 52-53 hours after compounding, respectively. The mean +/- S.D. pH values of the high-magnesium solutions were 7.96 +/- 0.02 and 7.98 +/- 0.01 at 3-4 and 52-53 hours after compounding, respectively. The electrolyte and glucose concentrations in the low- and high-magnesium solutions were similar 3-4 and 50-51 hours after preparation.
CONCLUSION
Magnesium sulfate 1.5 meq/L and sodium bicarbonate 50 meq/L were physically compatible in a pharmacy-compounded hemofiltration solution for 48 hours when stored at 22-25 degrees C without protection from light.
Topics: Dialysis Solutions; Drug Compounding; Drug Incompatibility; Drug Storage; Electrolytes; Glucose; Hemofiltration; Hydrogen-Ion Concentration; Magnesium Sulfate; Pharmaceutical Solutions; Pharmacy Service, Hospital; Sodium Bicarbonate
PubMed: 20237384
DOI: 10.2146/ajhp090342 -
The Cochrane Database of Systematic... Dec 2010Eclampsia, the occurrence of a seizure in association with pre-eclampsia, remains a rare but serious complication of pregnancy. A number of different anticonvulsants are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Eclampsia, the occurrence of a seizure in association with pre-eclampsia, remains a rare but serious complication of pregnancy. A number of different anticonvulsants are used to control eclamptic fits and to prevent further fits.
OBJECTIVES
The objective of this review was to assess the effects of magnesium sulphate compared with diazepam when used for the care of women with eclampsia. Magnesium sulphate is compared with phenytoin and with lytic cocktail in other Cochrane reviews.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2010) and CENTRAL (2010, Issue 3).
SELECTION CRITERIA
Randomised trials comparing magnesium sulphate (intravenous or intramuscular administration) with diazepam for women with a clinical diagnosis of eclampsia.
DATA COLLECTION AND ANALYSIS
Two authors assessed and extracted data independently.
MAIN RESULTS
We have included seven trials, involving 1396 women. Three trials (1030 women) were good quality. Magnesium sulphate was associated with a reduction in maternal death (seven trials;1396 women; risk ratio (RR) 0.59, 95% confidence interval (CI) 0.38 to 0.92) and recurrence of seizures (seven trials;1390 women; RR 0.43, 95% CI 0.33 to 0.55) compared to diazepam. There were no clear differences in other measures of maternal morbidity.There was no clear difference in perinatal mortality (four trials; 788 infants; RR 1.04, 95% CI 0.81 to 1.34) or neonatal mortality (four trials; 759 infants; RR 1.18, 95% CI 0.75 to 1.84). In the magnesium sulphate group, fewer liveborn babies had an Apgar score less than seven at one minute (two trials; 597 babies; RR 0.75, 95% CI 0.65 to 0.87) or at five minutes (RR 0.70, 95% CI 0.54 to 0.90), and fewer appeared to need intubation at the place of birth (two trials; 591 infants; RR 0.67, 95% CI 0.45 to 1.00). There was no difference in admission to a special care nursery (four trials; 834 infants; RR 0.91, 95% CI 0.79 to 1.05), but fewer babies in the magnesium sulphate group had a length of stay more than seven days (three trials 631 babies; RR 0.66, 95% CI 0.46 to 0.96).
AUTHORS' CONCLUSIONS
Magnesium sulphate for women with eclampsia reduces the risk ratio of maternal death and of recurrence of seizures, compared with diazepam.
Topics: Anticonvulsants; Diazepam; Eclampsia; Female; Humans; Injections, Intramuscular; Injections, Intravenous; Magnesium Sulfate; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 21154341
DOI: 10.1002/14651858.CD000127.pub2 -
BJOG : An International Journal of... Feb 2022Hypertensive disorders account for 14% of global maternal deaths. Magnesium sulphate (MgSO ) is recommended for prevention and treatment of pre-eclampsia/eclampsia.... (Review)
Review
BACKGROUND
Hypertensive disorders account for 14% of global maternal deaths. Magnesium sulphate (MgSO ) is recommended for prevention and treatment of pre-eclampsia/eclampsia. However, MgSO remains underused, particularly in low- and middle-income countries (LMICs).
OBJECTIVE
This qualitative evidence synthesis explores perceptions and experiences of healthcare providers, administrators and policy-makers regarding factors affecting use of MgSO to prevent or treat pre-eclampsia/eclampsia.
SEARCH STRATEGY
We searched MEDLINE, EMBASE, Emcare, CINAHL, Global Health and Global Index Medicus, and grey literature for studies published between January 1995 and June 2021.
SELECTION CRITERIA
Primary qualitative and mixed-methods studies on factors affecting use of MgSO in healthcare settings, from the perspectives of healthcare providers, administrators and policy-makers, were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
We applied a thematic synthesis approach to analysis, using COM-B behaviour change theory to map factors affecting appropriate use of MgSO .
MAIN RESULTS
We included 22 studies, predominantly from LMICs. Key themes included provider competence and confidence administering MgSO (attitudes and beliefs, complexities of administering, knowledge and experience), capability of health systems to ensure MgSO availability at point of use (availability, resourcing and pathways to care) and knowledge translation (dissemination of research and recommendations). Within each COM-B domain, we mapped facilitators and barriers to physical and psychological capability, physical and social opportunity, and how the interplay between these domains influences motivation.
CONCLUSIONS
These findings can inform policy and guideline development and improve implementation of MgSO in clinical care. Such action is needed to ensure this life-saving treatment is widely available and appropriately used.
TWEETABLE ABSTRACT
Global qualitative review identifies factors affecting underutilisation of MgSO for pre-eclampsia and eclampsia.
Topics: Adult; Attitude of Health Personnel; Eclampsia; Female; Health Knowledge, Attitudes, Practice; Health Personnel; Health Services Accessibility; Humans; Magnesium Sulfate; Pre-Eclampsia; Pregnancy; Qualitative Research; Tocolytic Agents; Translational Science, Biomedical
PubMed: 34520111
DOI: 10.1111/1471-0528.16913