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

NCT05229055 | Unknown Phase 2

• 1 other identifier: Intranasal ketamine
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (2)

• VAS decrease of more than 50% comparing to initial value at 30 minutes following analgesia administration

  resolution of pain with decrease of VAS more than 50% comparing to initial value

  30 minutes

• rate of severe adverse events

  occurence of severe adverse events

  120 minutes

Secondary Outcomes (2)

• rate of rescue analgesia 1 doses of morphine required to reach efficient analgesia

  30 minutes

• rate of rescue analgesia 2 doses of morphine required to reach efficient analgesia

  120 minutes

Study Arms (2)

Intranasal ketamine

ACTIVE COMPARATOR

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).

Drug: Ketamine

subcutanous ketamine

ACTIVE COMPARATOR

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.

Drug: Ketamine

Interventions

Ketamine DRUG

giving ketamine intranasal

Also known as: ketalar

Intranasal ketamine; subcutanous ketamine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

university of Monastir

Monastir, 5000, Tunisia

RECRUITING

Related Publications (11)

• Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.

  PMID: 17306626 BACKGROUND

• Guirimand F, Dupont X, Brasseur L, Chauvin M, Bouhassira D. The effects of ketamine on the temporal summation (wind-up) of the R(III) nociceptive flexion reflex and pain in humans. Anesth Analg. 2000 Feb;90(2):408-14. doi: 10.1097/00000539-200002000-00031.

  PMID: 10648330 BACKGROUND

• Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.

  PMID: 10467917 BACKGROUND

• Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.

  PMID: 24127709 BACKGROUND

• Galinski M, Dolveck F, Combes X, Limoges V, Smail N, Pommier V, Templier F, Catineau J, Lapostolle F, Adnet F. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007 May;25(4):385-90. doi: 10.1016/j.ajem.2006.11.016.

  PMID: 17499654 BACKGROUND

• Strigo IA, Duncan GH, Bushnell CM, Boivin M, Wainer I, Rodriguez Rosas EM, Persson J. The effects of racemic ketamine on painful stimulation of skin and viscera in human subjects. Pain. 2005 Feb;113(3):255-264. doi: 10.1016/j.pain.2004.10.023.

  PMID: 15661431 BACKGROUND

• Smith DC, Mader TJ, Smithline HA. Low dose intravenous ketamine as an analgesic: a pilot study using an experimental model of acute pain. Am J Emerg Med. 2001 Oct;19(6):531-2. doi: 10.1053/ajem.2001.27152. No abstract available.

  PMID: 11593484 BACKGROUND

• Andolfatto G, Innes K, Dick W, Jenneson S, Willman E, Stenstrom R, Zed PJ, Benoit G. Prehospital Analgesia With Intranasal Ketamine (PAIN-K): A Randomized Double-Blind Trial in Adults. Ann Emerg Med. 2019 Aug;74(2):241-250. doi: 10.1016/j.annemergmed.2019.01.048. Epub 2019 Mar 27.

  PMID: 30926189 BACKGROUND

• Shrestha R, Pant S, Shrestha A, Batajoo KH, Thapa R, Vaidya S. Intranasal ketamine for the treatment of patients with acute pain in the emergency department. World J Emerg Med. 2016;7(1):19-24. doi: 10.5847/wjem.j.1920-8642.2016.01.003.

  PMID: 27006733 BACKGROUND

• Tuchscherer J, McKay WP, Twagirumugabe T. Low-dose subcutaneous ketamine for postoperative pain management in Rwanda: a dose-finding study. Can J Anaesth. 2017 Sep;64(9):928-934. doi: 10.1007/s12630-017-0914-0. Epub 2017 Jun 19.

  PMID: 28631150 BACKGROUND

• Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.

  PMID: 15621365 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nouira Semir, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira Semir, Professor

CONTACT

73106046; semir.nouira@rns.tn

Bel Hadj Ali Khaoula, MD

CONTACT

73106000; belhadjalikhaoula@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Monastir Emergency departement

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: February 8, 2022
• Study Start: April 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 1, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)