Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain

NCT03511833 | Unknown Phase 3

• 1 other identifier: TASMC-18-PH-0459-17-CTIL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who present with acute traumatic injuries in the pre-hospital setting or to the emergency department (ED) are treated with opioids, the current gold standard for severe acute pain therapy. Treatment with opioids has many disadvantages: the need of skilled manpower to administer the medication IV, numerous side effects- mainly cardiorespiratory depression- which necessitates post medication administration continuous monitoring of patients. IV administration may be difficult or impossible to provide in a number of extreme circumstances. For these reasons, there is a constant search for alternate treatment options for pain in acute traumatic injuries. IN ketamine has only recently been studied favorably in our department in adults, in an open, prospective study (Shimonovich at al 2016), and warrants further investigation in the setting of acute traumatic pain. Ketamine is a safe and efficacious analgesic and is overall well received both by patients and physicians. Side effects include: hallucinations and dissociation. As opposed to opioids, ketamine does not alter patients' respiratory and hemodynamic stability giving ketamine great therapeutic potential for pain reduction in trauma patients, pre-hospital patients, and battlefield injuries. The study we are conducting is designed to test and analyze the safety and efficacy of IN Ketamine compared to IV morphine in a setting of acute traumatic pain in the ED, when both medications are administered by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.

Conditions

Acute Traumatic Pain

Keywords

Intra nasal ketamine; IV morphine; acute traumatic pain

Outcome Measures

Primary Outcomes (1)

• Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 2 hour post administration

  Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the 2 hours follow-up.

  2 hours

Secondary Outcomes (2)

• • adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 2 hour post administration ]

  2 hours

• • patient satisfaction [Interview] [ Time Frame: 2 hours post administration ]

  2 hours post administration

Study Arms (2)

Morphine group

ACTIVE COMPARATOR

Morphine group will receive IV medication and IN saline.

Drug: Morphine

Ketamine group

EXPERIMENTAL

Ketamine group will receive IV saline and IN medication.

Drug: Ketamine

Interventions

Morphine DRUG

IV morphine -0.1 mg/kg: Morphine vial contains 10 mg/10 ml = 1mg/ml ----\> 0.1 ml/kg

Also known as: no other Intervention name

Morphine group

Ketamine DRUG

IN ketamine: 1 mg/kg: Ketamine vial contains 100 mg/2 ml = 50mg/ml ---\> 0.02ml/kg

Also known as: no other Intervention name

Ketamine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be 18-70 years old
• self-report pain greater than or equal to 7/10 on a numerical-verbal scale
• weigh 50-100 kg
• have an ASA (American Society of Anaesthesiologists' classification) score of 1-2
• have systolic blood pressure of 90-160 mmHg

You may not qualify if:

• have had opioid analgesia administered within 2 hours of the study
• are chronic analgesia users (of opioid or others)
• have known allergies to morphine or ketamine
• have had a large meal within an hour prior to trauma
• are pregnant
• have a psychiatric history
• have nasal congestion, nasal trauma, epistaxis, or a deviated nasal septum
• have suffered any head or face trauma: any trauma that is manifested by an external mark in the face or skull.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Medical Corps, Israel Defense Force: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center, department of Emergency Medicine

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Interventions

Morphine; Ketamine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Pinchas Halpern, MD

CONTACT

+97236973829; DR_HALPERIN@tlvmc.gov.il

Daniel Trotzky, MD

CONTACT

+972507308675; danieltro@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, R&D Department

Model Details: Eligible patients will be randomized according to a blocked randomization scheme using www.sealedenvelope.com (site accessed Sep 10, 2017), which permits assignment of the participant to either group "A" or "group B" (the IN ketamine or IV morphine group). Only the pharmacy will have knowledge of which group is Ketamine and which group is Morphine. Eligible patients will be divided in equal proportions (58 in group A and 58 in group B). Both medications will be prepared by the pharmacy as coded kits, and will be stored in the ER safe with clear signage: "For ketamine/morphine clinical trial only". Shelf life of the kits is 6 months. Each vial in a kit will be marked by the group name either "A" or "B" and by either "IN" or "IV". The "IV" vials will either contain: morphine (10 mg of morphine in 10 ml saline) or 10 ml saline for IV administration, and the "IN" vials will either contain ketamine (100 mg in 2ml saline) or 2 ml saline for nasal administration.

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: April 30, 2018
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IL (1)