Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Dose Ketamine Intra Nasal Traumatology (Ket)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 14, 2017
First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
Pain resolution [ Time Frame: 30 minutes ]
- Treatment succes: Resolution of pain wtih decrease of VAS more than 50% comparing to initial value at 30 minutes following analgesia administration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
  • Intolerance to treatement and adverse events [ Time Frame: 30 minutes and at 120 minutes ]
    Noticing any sign of intolerance due to treatement : Dizziness , Vomiting..
  • Percentage of patients with VAS <30 mm at discharge [ Time Frame: 120 minutes ]
    percentage of patients discharged from the ED with VAS <30.
  • Number and percentage of patients who required non opiods analgesics [ Time Frame: 30 minutes ]
    Requirement of non-opioids analgesic agents
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Intolerance to treatement and adverse events [ Time Frame: 30 minutes ]
    Noticing any sign of intolerance due to treatement : Dizziness , Vomiting..
  • Pain resolution time [ Time Frame: 1 hour ]
    time between the start of the analgesic treatment and the one when VAS decreases to less than 3.
  • The need for rescue analgesia [ Time Frame: 30 minutes ]
    The need for rescue analgesia and dose of morphine required
  • satisfaction [ Time Frame: 1 hour ]
    Satisfaction of patients evaluated with the likert score at the ED discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Ketamine Intra Nasal Traumatology
Official Title  ICMJE Intranasal Ketamine for Treatment of Acute Pain in the Emergency Department : A Randomized Controlled Trial
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Trauma
Intervention  ICMJE
  • Drug: Ketamine
    25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received
  • Drug: Placebo
    0.5 mL of normal saline solution as a placebo in one pulverisation per nostril
    Other Name: normal saline solution
Study Arms  ICMJE
  • Placebo Comparator: placebo group
    Intranasal placebo pulverisation
    Intervention: Drug: Placebo
  • Active Comparator: Ketamine group
    Intranasal ketamine pulverisation
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2019)
1102
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
1000
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03233035
Other Study ID Numbers  ICMJE Ket-Int-Nas-TR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pr. Semir Nouira, University of Monastir
Study Sponsor  ICMJE University of Monastir
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nouira Semir, Professor university Hospital of Monastir
PRS Account University of Monastir
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP