Low Dose Ketamine Intra Nasal Traumatology

Study Overview
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Brief Summary
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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
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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

Official Title
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Intranasal Ketamine for Treatment of Acute Pain in the Emergency Department : A Randomized Controlled Trial

Conditions
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Trauma

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study includes patients aged 18 to 80 years who presented to the ED with acute limb trauma pain with a visual analgesic 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blind Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>Intranasal placebo pulverisation | Drug: Placebo<br>* 0.5 mL of normal saline solution as a placebo in one pulverisation per nostril<br>* Other names: normal saline solution;|
| Active Comparator: Ketamine group<br>Intranasal ketamine pulverisation | Drug: Ketamine<br>* 25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of patients who need rescue opiods in the two groups | the need for rescue opioids during ED stay | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intolerance to treatement and adverse events | Noticing any sign of intolerance due to treatement : Dizziness , Vomiting.. | 30 minutes and at 120 minutes | 
| Percentage of patients with VAS <30 mm at discharge | percentage of patients discharged from the ED with VAS <30. | 120 minutes | 
| Number and percentage of patients who required non opiods analgesics | Requirement of non-opioids analgesic agents | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine-Intranasal-Acute pain-Emergency departement