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临床试验/NCT03511833
NCT03511833Unknown3 期

Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
120
试验地点
1
主要终点
Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 2 hour post administration

研究概览

简要总结

Patients who present with acute traumatic injuries in the pre-hospital setting or to the emergency department (ED) are treated with opioids, the current gold standard for severe acute pain therapy. Treatment with opioids has many disadvantages: the need of skilled manpower to administer the medication IV, numerous side effects- mainly cardiorespiratory depression- which necessitates post medication administration continuous monitoring of patients. IV administration may be difficult or impossible to provide in a number of extreme circumstances. For these reasons, there is a constant search for alternate treatment options for pain in acute traumatic injuries. IN ketamine has only recently been studied favorably in our department in adults, in an open, prospective study (Shimonovich at al 2016), and warrants further investigation in the setting of acute traumatic pain. Ketamine is a safe and efficacious analgesic and is overall well received both by patients and physicians. Side effects include: hallucinations and dissociation. As opposed to opioids, ketamine does not alter patients' respiratory and hemodynamic stability giving ketamine great therapeutic potential for pain reduction in trauma patients, pre-hospital patients, and battlefield injuries. The study we are conducting is designed to test and analyze the safety and efficacy of IN Ketamine compared to IV morphine in a setting of acute traumatic pain in the ED, when both medications are administered by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.

详细描述

The procedure:

  1. Eligible patients will be identified by the ED personnel. They will make sure to inquire about and also visually inspect the patient's nares regarding nasal congestion, deviated septum, obstruction or injury.
  2. Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
  3. The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
  4. According to physician order (IV amount and IN amount) and patient group assignment, the nurse will prepare two blinded syringes that will be marked "A" or "B" (the assigned group) and "IN" or "IV" and note in the data sheet the time of syringe preparation.
  5. The IV syringe will contain either Morphine or Normal Saline (up to 10 ml), and the IN syringe will contain either Ketamine or Normal saline (up to 2 ml).
  6. The amount in the syringes will be calculated based on the patients' weight:

IV-0.1 mg/kg: Morphine vial contains 10 mg/10 ml = 1mg/ml ----> 0.1 ml/kg IN-1 mg/kg: Ketamine vial contains 100 mg/2 ml = 50mg/ml ---> 0.02ml/kg 7. Administration of the medication is limited to one hour from preparation in the syringe. 8. The nurse will hand the syringes to the researcher (blinded and coded) and note in the data sheet the time of administration and the amount to administer IN and IV. 9. Prior to administering medication to the patient the researcher will measure vital signs (blood pressure, heart rate, respiratory rate, and O2 saturation) as well as pain level on a 100 mm VAS (visual analogue scale) questionnaire. 10. After administration of medications the researcher will measure vital signs (blood pressure, heart rate, respiratory rate, and O2 saturation) as well as pain level on a 100 mm VAS questionnaire every 5 minutes for the first 30 minutes and then every 15 minutes after that at 30, 45, 60, and 90 minutes.

Saturation >95% on room air; if lower than 90%, the patient will be placed on 40% oxygen mask. 11. Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED. 12. If the patient will be moved to another department from the ED, they will be withdrawn from the study. 13. Cardiorespiratory follow-up (as per bullet point number 8 above), will be concluded at 1.5 hours post-intervention, and clinical follow-up will continue as long as the patient remains in the ED. 14. 90 minutes after drug administration, if pain had not subsided sufficiently according to treating physician's clinical assessment, patient will receive further analgesic medications by physician order, as per ED protocol. The protocol takes into account concurrent medications (in this case either morphine or ketamine. Neither morphine nor ketamine will be used in these patients after test drug administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be 18-70 years old
  • self-report pain greater than or equal to 7/10 on a numerical-verbal scale
  • weigh 50-100 kg
  • have an ASA (American Society of Anaesthesiologists' classification) score of 1-2
  • have systolic blood pressure of 90-160 mmHg

排除标准

  • have had opioid analgesia administered within 2 hours of the study
  • are chronic analgesia users (of opioid or others)
  • have known allergies to morphine or ketamine
  • have had a large meal within an hour prior to trauma
  • are pregnant
  • have a psychiatric history
  • have nasal congestion, nasal trauma, epistaxis, or a deviated nasal septum
  • have suffered any head or face trauma: any trauma that is manifested by an external mark in the face or skull.

研究组 & 干预措施

Morphine group

Active Comparator

Morphine group will receive IV medication and IN saline.

干预措施: Morphine (Drug)

Ketamine group

Experimental

Ketamine group will receive IV saline and IN medication.

干预措施: Ketamine (Drug)

结局指标

主要结局

Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 2 hour post administration

时间窗: 2 hours

Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the 2 hours follow-up.

次要结局

  • • adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 2 hour post administration ](2 hours)
  • • patient satisfaction [Interview] [ Time Frame: 2 hours post administration ](2 hours post administration)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

michal roll

Director, R&D Department

Tel-Aviv Sourasky Medical Center

研究点 (1)

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