TRAUMA
Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(8):14 BMC Emerg Med. 2016 Nov 9;16(1):4390 patients presenting to the emergency department with moderate to severe pain due to mild or moderate blunt trauma were randomized to be managed with either intranasal (IN) ketamine, intravenous (IV) morphine, or intramuscular (IM) morphine. Patients were assessed for pain every 5 minutes for the first 60 minutes after administration. Results demonstrated significantly earlier onset of clinically relevant pain reduction in the IN ketamine and IV morphine groups compared to the IM morphine group. Adverse events related to confusion, dizziness, and difficulty concentrating were more frequent following IN ketamine administration, while morphine administration was associated with a greater incidence of dry mouth.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
1/4
Randomization
2/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Patients presenting to the orthopaedic emergency department are often in a significant amount of pain. Opiates have traditionally been used as a form of analgesia in these patients. The use of these drugs often requires close monitoring of patients, as hemodynamic or respiratory complications can be quite common. Interest has increased in the possible use of intranasal ketamine in the treatment of these patients, avoiding not only the need for the monitoring associated with opioids, but also avoiding the administration of injections. There is a paucity of evidence evaluating the use of intranasal ketamine in this setting; hence, the need for this study.
主な研究課題は何ですか？
In the management of pain for patients presenting to the ED with traumatic limb or spine injuries, what is the efficacy and safety of intranasal ketamine, compared to either intravenous morphine or intramuscular morphine, when assessed over the first 60 minutes after admittance?
重要な知見は？
- Time to clinically relevant pain reduction was significantly shorter in the IN ketamine group (14.3min [95%CI 9.8-18.8]) and the IV morphine group (8.9min [95%CI 6.6-11.2]) compared to the IM morphine group (26.0min [95%CI 20.3-31.7]) (p=0.003 and 0.000, respectively); there was no significant difference between the IN ketamine group and the IV morphine group (p=0.300).
- Overall maximum VAS pain reduction within the first 60 minutes did not significantly differ between the IN ketamine group (56mm), IV morphine group (59mm), and the IM morphine group (48mm) (p=0.300).
- No significant differences in the percentage of patients who did not demonstrate a clinically relevant pain reduction were observed between groups.
- Adverse event monitoring demonstrated a significantly higher incidence of difficulty concentrating in the IN ketamine group compared to the two morphine groups. The was also a significantly higher incidence of confusion in the IN ketamine group compared to the IV morphine group, and a significantly higher incidence of dizziness in the IN ketamine group compared to the IM morphine group. Adverse events related to dry mouth were significantly more frequent in the morphine groups compared to the IN ketamine group.
- Overall, no significant difference in the degree of patient satisfaction was observed between the IN ketamine group (58.7mm [95%CI 45.3-72.1]), IV morphine group (70.2mm [95%CI 55.2-85.2]), and IM morphine group (73.9mm [95%CI 62.9-84.9]).
- No statistically significant differences in vital signs were observed between the three groups.
最も覚えておくべきことは？
In the management of pain for those presenting to emergency departments with traumatic limb or spine injuries, the use of intranasal ketamine demonstrated similar analgesic efficacy and hemodynamic/respiratory safety over 60 minutes after administration when compared to intravenous morphine. Both intranasal ketamine and intravenous morphine demonstrated significantly more rapid onset of analgesia when compared to intramuscular morphine.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that intranasal administration of ketamine may offer an effective alternative and easier-to-administer method of acute analgesia to intravenous morphine in managing patients in emergency departments with severe pain due to blunt trauma resulting in limb and spine injuries.
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