Low Dose Ketamine Intra Nasal Traumatology
Condition: Trauma
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine
      analgesic agents in patients with moderate to severe pain in the ED in reducing the need for
      opioid or non opioids analgesic agents.
    

Detailed description: 
      Intranasal ketamine for treatment of acute pain in the emergency department : A randomized
      controlled trial

      Introduction :

      Pain is the most common complaint for emergency department (ED) visits [1].The provision of
      adequate, safe, and timely analgesia is a core component of patient care in the emergency
      department (ED). Ketamine is a noncompetitive Nmethyl- D-aspartate and glutamate receptor
      antagonist that decreases central sensitization, "wind-up" phenomena, and pain memory [2,3].

      At subdissociative doses (0.1 to 0.6 mg/kg; most commonly 0.3 mg/kg) maintains potent
      analgesic and amnestic effects that are accompanied by preservation of protective airway
      reflexes, spontaneous respiration, and cardiopulmonary stability [4-6].

      Intranasal route ….

      Objective of the study :

      To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine
      analgesic agents in patients with moderate to severe pain in the ED in reducing the need for
      opioid or class III analgesic agents.

      Materials and Methods :

      Study design :

      It is a ramdomized, prospective, double blind, controlled, multicentric trial. The study is
      registered with clinical.tria.gov (…….).

      Study Setting and Selection of Participants :

      The trial is conducted in three community teaching hospitals :

        -  Emergency department, fattouma bourguiba university hospital, monastir, tunisia

        -  Emergency department, sahloul university hospital, sousse, tunisia

        -  Emergency department, farhat hached university hospital, sousse, tunisia

      ED principal investigators maintain the randomization list, which is generated before the
      start of the study, prepare the medication, and deliver it to the treating physician in a
      blinded manner.

      Inclusion criteria :

      The study includes patients aged 18 to 80 years who presented to the ED with acute limb
      trauma pain with a visual analogue scale (VAS) of 5 or more on a standard 11- point (0 to
      10). An informed consent is necessary.

      Exclusion criteria :

        -  Pregnancy,

        -  Breast-feeding,

        -  Altered mental status,

        -  Allergy to ketamine or morphine or

        -  Weight less than 46 kg or greater than 115 kg,

        -  Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150
           beats/min, and respiration rate <10 or >30 breaths/min),

        -  Medical history of acute head or eye injury, seizure, intracranial hypertension, chronic
           pain, severre renal or hepatic insufficiency,

        -  Alcohol or drug abuse,

        -  Psychiatric illness,

        -  Recent (4 hours before) analgesic agent use.

      Protocol :

      In the triage area, each patient having the inclusion criteria receives 25mg of ketamine in
      0.5 ml of serum saline in one pulverisation per nostril or 0.5 mL of normal saline solution
      in one pulverisation per nostril as a placebo according to the predetermined randomization
      list. None of the treating physician or nurses is aware about the medication received. In all
      patients included, the investigators collect vital signs ; demographic and clinical data.

      Study investigators record VAS, and adverse effects at 15, 30, 60, 90, and 120 minutes.

      At 30 minutes, if patients report a pain numeric rating scale score of 5 or greater and
      request additional pain relief, titrated morphine is administered as a rescue analgesic with
      a dose of 0.1 mg/Kg repeated every 3 to 5 minutes if the pain numeric rating scale score is
      still greater or equal to 3.

      All data recorded on data collection sheets, including sex, demographics, medical history,
      and vital signs, were entered into SPSS (version 20.0; IBM Corp) by the research manager.

      Patients's informed consent is obtained. The ethic commitee of our institution approved the
      study.

      Endpoints :

      Primary endpoints :

      - Need for rescue opioids during ED stay

      Secondary endpoints :

        -  requirement of non-opioids analgesic agents.

        -  percentage of patients discharged from the ED with VAS <30.

        -  Safety : adverse events
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received; 0.5 mL of normal saline solution as a placebo in one pulverisation per nostril
Other intervention name(s): normal saline solution
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ketamine-Intranasal-Acute pain-Emergency departement