Efficacy and Safety of Intranasal Ketamine for Acute Pain Management in the Emergency Setting: A Systematic Review and Meta-Analysis.
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SUBMITTER: Seak YS
PROVIDER: S-EPMC8432265 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundKetamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine.MethodsA single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction.ResultsThe 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively.ConclusionsIN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications.Trial registrationRetrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.
| S-EPMC5103427 | biostudies-literature
Project description:Study objectiveTo assess the efficacy and safety of intranasal analgesic-dose ketamine as compared to intranasal fentanyl for pediatric acute pain.MethodsA systematic review and meta-analysis was performed following the PRISMA guidelines. We searched PubMed, Embase, and Scopus databases for randomized controlled trials from inception to December 2019. We conducted meta-analysis with random-effects models to evaluate pain reduction, rescue analgesia, adverse events and sedation between intranasal ketamine and intranasal fentanyl. Random-effects models were used to estimate weighted mean differences (WMD) and pooled relative risks (RR).ResultsA total of 546 studies were screened and 4 trials were included. In the meta-analysis of 4 studies including 276 patients, ketamine had similar reductions in pain scores from baseline to all post-intervention times (10 to 15 min: WMD -1.42, 95% CI -9.95 to 7.10; 30 min: WMD 0.40, 95% CI -6.29 to 7.10; 60 min: WMD -0.64, 95% CI -6.76 to 5.47). Ketamine was associated with similar rates of rescue analgesia (RR 0.74, 95% CI 0.44 to 1.25). Ketamine had a higher risk of non-serious adverse events (RR 2.00, 95% CI 1.43 to 2.79), and no patients receiving ketamine had a serious adverse event. There was one serious adverse event (hypotension) with fentanyl that self-resolved. No patients receiving either IN fentanyl or ketamine had significant sedation.ConclusionIntranasal analgesic-dose ketamine may be considered as an alternative to opioids for acute pain management in children. Its accepted use will depend on the tolerability of non-serious adverse events and the desire to avoid opioids.
| S-EPMC7572639 | biostudies-literature
Project description:BackgroundSubanesthetic ketamine has been used for treatment-resistant depression and is popular as an opioid-sparing agent.ObjectiveThe present study aimed to investigate the dose-dependent antinociceptive effect of intranasal ketamine (INK) along with behavioral and neurophysiological safety in mice.MethodsAntinociceptive efficacy was evaluated in the terms of thermal nociceptive response and formalin test. The safety studies were carried out separately in healthy mice using telemetry-based cortical electroencephalography, hemodynamic changes, and spontaneous behavioral functions, including anxiety, stereotypic movement, and locomotor functions.ResultsINK administration significantly augmented the thermal nociceptive threshold and alleviated the pain response in the tonic phase of the formalin test. The results showed the dose-independent effectiveness of ketamine for thermal nociceptive responses because there were no significant differences among different INK dose groups. Behavioral safety analysis using the open field exploratory test revealed no significant effect of INK on anxiety-like functions in healthy mice. However, INK mice showed significantly more stereotypic movement but slower locomotor activities. The electroencephalography signal power spectrum density analysis revealed no significant changes by INK administration except a lower value in the α range. No significant changes were reported in heart rate, diastolic blood pressure, or systolic blood pressure at the higher dose equivalent used in the pain model.ConclusionsThe study demonstrated the behavioral and neurophysiological safety of INK, although it had a mild sedative effect. Therefore, INK is suggested as a potentially safe candidate for the management of acute pain. (Curr Ther Res Clin Exp. 2021; 82:XXX-XXX)© 2021 Elsevier HS Journals, Inc.
| S-EPMC8296084 | biostudies-literature
Project description:BackgroundGiven the inadequate control of pain in patients with the trauma that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients.Materials and methodsThe current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1 μg/kg intranasal fentanyl group (n = 44). Then pain scores, heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded at baseline, 5, 10, 15, 30, and 40 min after the intervention.ResultsVisual analog scale (VAS) scores of patients in the intranasal ketamine group 5 and 10 min after the intervention were 61.50 ± 20.45 and 55.00 ± 21.96, respectively. The mentioned scores were significantly lower than the VAS scores of patients in the control group with the mean of 72.44 ± 22.11 and 66.59 ± 24.25 and the VAS scores of patients in the intranasal fentanyl group with the mean of 71.59 ± 22.09 and 65.00 ± 22.87 at 5 and 10 min after the intervention, respectively (P < 0.05).ConclusionGiven the onset of action in < 10 min, intranasal ketamine can be proposed as an appropriate analgesic medication in pain reduction of patients with isolated limb injuries. Moreover, the incidence rate and severity of adverse effects were insignificantly higher in the intranasal ketamine group as compared with the intranasal fentanyl group.
| S-EPMC8943598 | biostudies-literature
Project description:Currently ketamine is not used often as an analgesic in the emergency department (ED). Nonetheless, it can increase the efficiency of opioids and decrease their side effects. The purpose of this systematic review and meta-analysis was to evaluate whether low-dose ketamine in the ED provides better analgesia with fewer adverse effects.The PubMed, EMBASE, and Cochrane Library databases were searched by two reviewers independently (last search performed on January 2016). Data were also extracted independently.A total of 6 trials involving 438 patients were included in the current analysis. Our subgroup analysis of pain reduction indicates that the favorable effects of ketamine were similar or superior to those of placebo or opioids, although these effects were heterogeneous. However, low-dose ketamine was associated with a higher risk of neurological (relative risk [RR] = 2.17, 95% confidence interval [CI] = 1.37-3.42, P < 0.001) and psychological events (RR = 13.86, 95% CI = 4.85-39.58, P < 0.001). In contrast, the opioid group had a higher risk of major cardiopulmonary events (RR = 0.22, 95% CI = 0.05-1.01, P = 0.05).The efficiency of ketamine varies depending on the pain site, but low-dose ketamine may be a key agent for pain control in the ED, as it has no side effects. It may also help to reduce the side effects of opioids.
| S-EPMC5082866 | biostudies-literature
Project description:BackgroundApproximately 12 million Americans are affected with cancer. Of these, 53% experience pain at all stages of cancer. Pain may remain uncontrolled despite high-dose opioid therapy, and opioids have many well-documented harmful side effects. Intranasal ketamine has been shown to be effective in controlling breakthrough noncancer pain in a double-blind randomized control trial (DBRCT) by Carr et al in 2003 as well as to help with depression in a DBRCT by Lapidus et al in 2014. We seek to obtain preliminary data on the safety, feasibility, and utility of this novel technique for the treatment of uncontrolled cancer pain.ObjectiveThis study aimed to obtain preliminary data via a clinical trial addressing the safety, feasibility, pharmacokinetics, and pharmacodynamics of intranasal ketamine. These initial findings will be applied to a subsequent trial to determine the effectiveness and associated toxicities of ketamine in a larger sample of cancer patients and to address the compelling need to identify new, successful management therapies for cancer pain.MethodsThis is an institutional review board- and investigational new drug-approved, prospective phase I/II trial to investigate the safety and use of intranasal ketamine in patients with uncontrolled pain related to cancer or cancer treatment. Informed consent will be obtained prior to all study procedures. All patients will be assigned to the same investigational treatment arm. After patient selection via inclusion/exclusion criteria, patients will be seen over 5 visits, with each visit conducted 2-7 days apart. Patients will be administered ketamine on visits 1-4 and monitored for 240 minutes with continuous pulse oximetry and regular blood pressure checks. Blood samples as well as patient-reported outcomes will be collected at set time points at baseline and after drug delivery. Patients will receive 10 mg intranasal ketamine on visit 1, 10 mg intravenous ketamine on visit 2, 30 mg intranasal ketamine on visit 3, and 50 mg intranasal ketamine on visit 4. On visit 5, an addition blood sample will be drawn.ResultsAs of March 2019, enrollment is in progress, and a total of 7 subjects have completed the study. Enrollment is expected to be completed by April 2019. Final data analysis will commence soon after, and the results are expected to be submitted for publication in 2019.ConclusionsIf intranasal ketamine can be utilized for pain control in cancer patients, it could provide superior analgesia and better quality of life, without the risk of significant respiratory depression and constipation associated with opioid medications. These findings will be an important initial step toward testing the effectiveness of intranasal ketamine as a nonopioid medication for cancer pain and as potential maintenance outpatient therapy.Trial registrationClinicalTrials.gov NCT03146806; https://clinicaltrials.gov/ct2/show/NCT03146806.International registered report identifier (irrid)DERR1-10.2196/12125.
| S-EPMC6658277 | biostudies-literature
Project description:Background and objectivesThe goal of this meta-analysis study was to perform a systematic review of the literature on the effects of ketamine on postoperative pain following tonsillectomy and adverse effects in children.Subjects and methodsTwo authors independently searched three databases (MEDLINE, SCOPUS, Cochrane) from their inception of article collection to February 2014. Studies that compared preoperative ketamine administration (ketamine groups) with no treatment (control group) or opioid administration (opioid group) where the outcomes of interest were postoperative pain intensity, rescue analgesic consumption, or adverse effects (sedation, nausea and vomiting, bad dream, worsening sleep pattern, and hallucination) 0-24 hours after leaving the operation room were included in the analysis.ResultsThe pain score reported by the physician during first 4 hours and need for analgesics during 24 hours postoperatively was significantly decreased in the ketamine group versus control group and was similar with the opioid group. In addition, there was no significant difference between ketamine and control groups for adverse effects during 24 hours postoperatively. In the subgroup analyses (systemic and local administration) regarding pain related measurements, peritonsillar infiltration of ketamine was more effective in reducing the postoperative pain severity and need for analgesics.ConclusionPreoperative administration of ketamine systemically or locally could provide pain relief without side-effects in children undergoing tonsillectomy. However, considering the insufficient evaluation of efficacy of ketamine according to the administration methods and high heterogeneity in some parameters, further clinical trials with robust research methodology should be conducted to confirm the results of this study.
| S-EPMC4076328 | biostudies-literature
Project description:BackgroundIntranasal agents may be ideal for the treatment of migraine patients. Many new acute intranasal-specific therapies have been developed, but few of them have been directly compared. The aim of this network meta-analysis (NMA) was to compare the efficacy and safety of various intranasal agents for the treatment of acute migraine in adult patients.MethodsThe Cochrane Register of Controlled Trials, Embase, and PubMed were searched from inception to 15 August 2023. Randomized controlled trials (RCTs) using intranasal agents (no restrictions on dose, formulation, dosing regimen or timing of the first dose) to treat adult patients with acute migraine were included. The primary efficacy endpoint was pain freedom at 2 h, and the primary safety endpoint was adverse events (AEs). The analysis process followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.ResultsNineteen studies (21 RCTs, 9738 participants) were included. Compared to the placebo, 5 mg of zolmitriptan using a conventional liquid nasal spray device was the most effective for pain freedom at 2 h [odds ratio (OR): 4.67, 95% confidence interval (CI): 3.43 to 6.43] and 24 h (OR: 5.49, 95% CI: 3.58 to 8.42) among all the interventions. Butorphanol nasal spray 1 mg was the most effective (OR: 8.62, 95% CI: 1.11 to 66.92) for pain freedom at 1 h, but with low-quality evidence. DFN-02 presented the highest freedom from nausea (OR: 4.95, 95% CI: 1.29 to 19.01) and phonophobia (OR: 5.36, 95% CI: 1.67 to 17.22) at 2 h, albeit with lower odds of achieving complete pain freedom. ROX-828 showed the highest improvement in freedom from photophobia at 2 h (OR: 4.03, 95% CI: 1.66 to 9.81). Dihydroergotamine nasal spray was significantly associated with the highest risk of AEs (OR: 9.65, 95% CI: 4.39 to 21.22) and was not recommended for routine use. Zavegepant nasal spray demonstrated the lowest risk of AEs (OR: 2.04, 95% CI: 1.37 to 3.03). The results of sensitivity analyses for the primary endpoints (pain freedom at 2 h and AEs) were generally consistent with those of the base case model.ConclusionsCompared with other new intranasal-specific therapies in treating migraine attacks, zolmitriptan nasal spray 5 mg was the most effective agent for pain freedom at 2 h. Zavegepant nasal spray 10 mg had the fewest adverse side effects.
| S-EPMC10506288 | biostudies-literature
Project description:IntroductionCarotid artery stenting (CAS) has increasingly emerged as an alternative strategy to carotid endarterectomy in the treatment of patients with symptomatic carotid stenosis. Optimal timing for CAS after symptoms onset remains unclear. We aimed to evaluate the safety and efficacy of CAS when performed in an emergency setting.Patients and methodsWe performed a retrospective analysis of CAS patients admitted to our CSC with symptomatic extracranial carotid occlusion or significant stenosis from January 2014-September 2019. Emergency CAS was defined as CAS performed during the same hospitalization from TIA/stroke onset, whereas elective CAS as CAS performed on a subsequent admission. The primary outcome was defined as the occurrence of any stroke, myocardial infarction, or death related to the procedure at 3 months of follow-up. Secondary outcomes included periprocedural complications and the rate of restenosis/occlusion at follow-up. Logistic regression and survival analyses were used to compare outcomes and restenosis at follow-up.ResultsWe identified 75 emergency and 104 elective CAS patients. Emergency CAS patients had significantly higher rates of ipsilateral carotid occlusion (17% vs. 2%, p < 0.001) and use of general anesthesia (19% vs. 4%, p = 0.001) than elective CAS. There were no significant differences between emergency and elective CAS in the primary (5.7% vs. 1%, p = 0.161) and secondary (9% vs. 4.8%, p = 0.232) outcomes. We did not find differences in the rate of restenosis/occlusion (7% vs. 11.6%; log-rank test p = 0.3) at a median of 13 months follow-up.ConclusionIn our study, emergency CAS in symptomatic patients might have a similar safety and efficacy profile to elective CAS at 3 months and long-term follow-up.
| S-EPMC8190945 | biostudies-literature
Project description:Despite the brevity of the procedure, bilateral myringotomy and tympanostomy tube placement (BMT) can result in significant postoperative pain and discomfort. As the procedure is frequently performed without intravenous access, non-parenteral routes of administration are frequently used for analgesia. The current study prospectively compares the efficacy of intranasal (IN) dexmedetomidine with IN fentanyl for children undergoing BMT.This prospective, double-blinded, randomized clinical trial included pediatric patients undergoing BMT. The patients were randomized to receive either IN dexmedetomidine (1 ?g/kg) or fentanyl (2 ?g/kg) after the induction of general anesthesia with sevoflurane. All patients received rectal acetaminophen (40 mg/kg) and the first 50 patients also received premedication with oral midazolam. Postoperative pain and recovery were assessed using pediatric pain and recovery scales, and any adverse effects were monitored for.The study cohort included 100 patients who ranged in age from 1 to 7.7 years and in weight from 8.6 to 37.4 kg. They were divided into 4 groups with 25 patients in each group: (1) midazolam premedication+IN dexmedetomidine; (2) midazolam premedication+IN fentanyl; (3) no premedication+IN dexmedetomidine; and (4) no premedication+IN fentanyl. Pain scores were comparable when comparing groups 2, 3 and 4, but were higher in group 1 (midazolam premedication with IN dexmedetomidine). There was no difference in total time in the post-anesthesia care unit (PACU) or time from arrival in the PACU until hospital discharge between the 4 groups. The heart rate (HR) was significantly lower in group 3 when compared to the other groups at several different times after arrival to the PACU. No clinically significant difference was noted in blood pressure.Following BMT, when no premedication is administered, there was no clinical advantage when comparing IN dexmedetomidine (1 ?g/kg) to IN fentanyl (2 ?g/kg). The addition of oral midazolam as a premedication worsened the outcome measures particularly for children receiving IN dexmedetomidine.
| S-EPMC4160729 | biostudies-literature