Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Acute Pain in the Emergency Department ( INVESCK )

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05229055
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Tracking Information
First Submitted Date  ICMJE November 20, 2021
First Posted Date  ICMJE February 8, 2022
Last Update Posted Date March 31, 2022
Actual Study Start Date  ICMJE February 21, 2022
Estimated Primary Completion Date July 21, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2022)
  • VAS decrease of more than 50% comparing to initial value at 30 minutes following analgesia administration [ Time Frame: 30 minutes ]
    resolution of pain with decrease of VAS more than 50% comparing to initial value
  • rate of severe adverse events [ Time Frame: 120 minutes ]
    occurence of severe adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2022)
  • rate of rescue analgesia 1 doses of morphine required to reach efficient analgesia [ Time Frame: 30 minutes ]
    The need for rescue analgesia
  • rate of rescue analgesia 2 doses of morphine required to reach efficient analgesia [ Time Frame: 120 minutes ]
    The need for rescue analgesia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Acute Pain in the Emergency Department ( INVESCK )
Official Title  ICMJE Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Acute Pain in the Emergency Department
Brief Summary Pain is the most common complaint for emergency department (ED) visit. Intranasal ketamine has been shown to provide rapid, well-tolerated, effective analgesia to emergency department (ED) patients with acute pain. few trials have studied ketamine infusion subcutaneously for pain management in trauma patients.
Detailed Description

Materials and methods :

Study design It is a randomized, prospective, double blind, controlled, multicentric trial.

Study setting and selection of participants :

The trial is conducted in three community teaching hospitals :

  • Emergency department, fattouma bourgiba university hospital, monastir, tunisia.
  • Emergency department, sahloul university hospital, sousse, tunisia.
  • Emergency department, farhat hached university hospital, sousse, tunisia.

Inculsion criteria :

The study includes patients aged 18 to 60 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 (0-10). An informed consent is necessary. Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.

The intranasal route Ketamine solution 250 mg/5ml was used. It was applied intranasally using a nasal spray pump where each spray delivered approximately 0.4 ml of solution corresponding to 20 mg of ketamine. After initial evaluation, each patient having the inclusion criteria receives one pulverisation (0.4 ml) per nostril of ketamine corresponding to a total dose of 20 mg of ketamine. Ketamine dosing was based on previous reports of intranasal ketamine use in ED patients, doses ranged from 0.45mg/kg to 1.25mg/kg.

The subcutaneous route :

Ketamine dosing by subcutanous route was based on previous reports use for post operative pain management. . The results of these reports revealed that low-dose ketamine 20-60 mg (0.5mg/kg for patients weighing 40-120 kg) showed an over all decrease in either the amount of opioid used or the amount of pain experienced. the investigators decided to chose a dose of 20mg of ketamine for all patients administered via 1ml insulin syringe once subcutaneously.

Protocol :

After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either subcutaneous or intanasal dose of ketamine as detailed above according to the predetermined randomization. To ensure a double-blind administration of ketamine ; patients enrolled in the intranasal ketamine group will receive concomitantly 1ml of normal saline solution subcutaneously, and patients enrolled in the subcutaneous ketamine group will receive concomitantly a spray of normal saline solution in each nostril. None of the treating physician or nurses are aware about the medication received. The included patients were followed and monitored until their discharge from the ED. All enrolled patients underwent close supervision of study staff to ensure safety. Study investigators record VAS, and adverse effects at 15, 30, 60, 90, and 120 minutes and at ED discharge. During ED stay, patients were monitored in order to evaluate the need for rescue analgesic treatment. At 30 minutes, if patients report a pain numeric rating scale score of 5 or greater and request additional pain relief, titrated morphine is adminstered as a rescue analgesic with a dose of 0.1mg/kg repeated every 3 to 5 minutes if the pain numeric rating scale score is still greater or equal to 3.

. Patients's informed consent is obtained.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The intranasal route Ketamine solution was used. Applying a nasal spray pump where each spray delivered 20 mg of ketamine. After initial evaluation, each patient having the inclusion criteria receives one pulverisation (0.4 ml) per nostril of ketamine corresponding to a total dose of 20 mg of ketamine.

The subcutaneous route :

Ketamine dosing by subcutanous route was based on previous reports use for post operative pain management. . The results of these reports revealed that low-dose ketamine 20-60 mg (0.5mg/kg for patients weighing 40-120 kg) showed an over all decrease in either the amount of opioid used or the amount of pain experienced (10, 11). For our study, we decided to chose a dose of 20mg of ketamine for all patients administered via 1ml insulin syringe once subcutaneously.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either subcutaneous or intanasal dose of ketamine as detailed above according to the predetermined randomization. To ensure a double-blind administration of ketamine ; patients enrolled in the intranasal ketamine group will receive concomitantly 1ml of normal saline solution subcutaneously, and patients enrolled in the subcutaneous ketamine group will receive concomitantly a spray of normal saline solution in each nostril. None of the treating physician or nurses are aware about the medication received.
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE Drug: Ketamine
giving ketamine intranasal
Other Name: ketalar
Study Arms  ICMJE
  • Active Comparator: Intranasal ketamine
    Ketamine solution 250 mg/5ml was used. It was applied intranasally using a nasal spray pump whereeach spray delivered approximately 0.4 ml of solution corresponding to 20 mg of ketamine. After initial evaluation, each patient having the inclusion criteria receives one pulverisation (0.4 ml) per nostril of ketamine corresponding to a total dose of 20 mg of ketamine. Ketamine dosing was based on previous reports of intranasal ketamine use in ED patients, doses ranged from 0.45mg/kg to 1.25mg/kg (9).
    Intervention: Drug: Ketamine
  • Active Comparator: subcutanous ketamine
    Ketamine dosing by subcutanous route was based on previous reports use for post operative pain management. . The results of these reports revealed that low-dose ketamine 20-60 mg (0.5mg/kg for patients weighing 40-120 kg) showed an over all decrease in either the amount of opioid used or the amount of pain experienced (10, 11).For our study, we decided to chose a dose of 20mg of ketamine for all patients administered via 1ml insulin syringe once subcutaneously.
    Intervention: Drug: Ketamine
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2022)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date July 21, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Patients 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 (0-10).

    • Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.

Exclusion Criteria:

  • Pregnancy/Breastfeeding

    • altered mental status (GCS<15)
    • Allergy to ketamine or morphine
    • Weight less than 40 kg or greater than 100kg
    • Unstable vital signs (systolic blood pressure <90 or > 180mmHg, pulse rate<50 or >150bpm, and respiration rate <10 or >30 breath/min)
    • Medical history of acute head or eye injury
    • Medical history of seizure
    • Medical history of intracranial hypertension,
    • Medical history of chronic pain,
    • Medical history of severe renal or hepatic insufficiency.
    • Medical history of glaucoma
    • 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 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nouira Semir, Professor 73106046 ext 216 semir.nouira@rns.tn
Contact: Bel Hadj Ali Khaoula, MD 73106000 ext 216 belhadjalikhaoula@yahoo.fr
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05229055
Other Study ID Numbers  ICMJE Intranasal ketamine
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Pr. Semir Nouira, University of Monastir
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Monastir
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nouira Semir, Professor University of Monastir
PRS Account University of Monastir
Verification Date March 2022

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