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Low Dose Ketamine Intra Nasal Traumatology (Ket)

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ClinicalTrials.gov Identifier: NCT03233035
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Brief 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.

Condition or disease Intervention/treatment Phase
Trauma Drug: Ketamine Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind Study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Ketamine versus placebo as a double blind study
Primary Purpose: Treatment
Official Title: Intranasal Ketamine for Treatment of Acute Pain in the Emergency Department : A Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: placebo group
Intranasal placebo pulverisation
Drug: Placebo
0.5 mL of normal saline solution as a placebo in one pulverisation per nostril
Other Name: normal saline solution

Active Comparator: Ketamine group
Intranasal ketamine pulverisation
Drug: Ketamine
25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received




Primary Outcome Measures :
  1. Number and percentage of patients who need rescue opiods in the two groups [ Time Frame: 30 minutes ]
    the need for rescue opioids during ED stay


Secondary Outcome Measures :
  1. Intolerance to treatement and adverse events [ Time Frame: 30 minutes and at 120 minutes ]
    Noticing any sign of intolerance due to treatement : Dizziness , Vomiting..

  2. Percentage of patients with VAS <30 mm at discharge [ Time Frame: 120 minutes ]
    percentage of patients discharged from the ED with VAS <30.

  3. Number and percentage of patients who required non opiods analgesics [ Time Frame: 30 minutes ]
    Requirement of non-opioids analgesic agents



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233035


Locations
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Tunisia
Nouira Samir
Monastir, Emergency Department Monastir, Tunisia 5000, Tunisia, 5000
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: Nouira Semir, Professor university Hospital of Monastir

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Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT03233035     History of Changes
Other Study ID Numbers: Ket-Int-Nas-TR
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Pr. Semir Nouira, University of Monastir:
Ketamine-Intranasal-Acute pain-Emergency departement

Additional relevant MeSH terms:
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Ketamine
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action