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Status unknownNCT03511833Updated Jun 25, 2019

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

A Phase 3 interventional study of Morphine and Ketamine in Acute Traumatic Pain, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-25.

Sponsored by Tel-Aviv Sourasky Medical Center · Phase 3, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The procedure:

  1. Eligible patients will be identified by the ED personnel. They will make sure to inquire about and also visually inspect the patient's nares regarding nasal congestion, deviated septum, obstruction or injury.
  2. Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
  3. The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
  4. According to physician order (IV amount and IN amount) and patient group assignment, the nurse will prepare two blinded syringes that will be marked "A" or "B" (the assigned group) and "IN" or "IV" and note in the data sheet the time of syringe preparation.
  5. The IV syringe will contain either Morphine or Normal Saline (up to 10 ml), and the IN syringe will contain either Ketamine or Normal saline (up to 2 ml).
  6. The amount in the syringes will be calculated based on the patients' weight:

    IV-0.1 mg/kg: Morphine vial contains 10 mg/10 ml = 1mg/ml ----> 0.1 ml/kg IN-1 mg/kg: Ketamine vial contains 100 mg/2 ml = 50mg/ml ---> 0.02ml/kg

  7. Administration of the medication is limited to one hour from preparation in the syringe.
  8. The nurse will hand the syringes to the researcher (blinded and coded) and note in the data sheet the time of administration and the amount to administer IN and IV.
  9. Prior to administering medication to the patient the researcher will measure vital signs (blood pressure, heart rate, respiratory rate, and O2 saturation) as well as pain level on a 100 mm VAS (visual analogue scale) questionnaire.
  10. After administration of medications the researcher will measure vital signs (blood pressure, heart rate, respiratory rate, and O2 saturation) as well as pain level on a 100 mm VAS questionnaire every 5 minutes for the first 30 minutes and then every 15 minutes after that at 30, 45, 60, and 90 minutes.

    Saturation >95% on room air; if lower than 90%, the patient will be placed on 40% oxygen mask.

  11. Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED.
  12. If the patient will be moved to another department from the ED, they will be withdrawn from the study.
  13. Cardiorespiratory follow-up (as per bullet point number 8 above), will be concluded at 1.5 hours post-intervention, and clinical follow-up will continue as long as the patient remains in the ED.
  14. 90 minutes after drug administration, if pain had not subsided sufficiently according to treating physician's clinical assessment, patient will receive further analgesic medications by physician order, as per ED protocol. The protocol takes into account concurrent medications (in this case either morphine or ketamine. Neither morphine nor ketamine will be used in these patients after test drug administration.
02

Conditions studied

  • Acute Traumatic Pain

Keywords

  • Intra nasal ketamine
  • IV morphine
  • acute traumatic pain
03

In context

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 553 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Morphine group

    Morphine group will receive IV medication and IN saline.

    Drug: Morphine

  • Experimental
    Ketamine group

    Ketamine group will receive IV saline and IN medication.

    Drug: Ketamine

Interventions

  • 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

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

    Also known as: no other Intervention name

06

What researchers measure

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.

    Time frame: 2 hours

Secondary outcomes

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

    Adverse effects were recorded at the end of two hours using the 'Opiate Related Symptom Distress Scale' and included measurements of the presence, frequency, intensity and disruptiveness of 12 common opiate side-effects. Among these were nausea, vomiting, urinary retention, constipation, difficulty concentrating, dizziness, confusion, and others.

    Time frame: 2 hours

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

    patients were asked to provide subjective comments

    Time frame: 2 hours post administration

07

Study locations

1 site
  • Tel Aviv Sourasky Medical Center, department of Emergency Medicine
    Tel Aviv, 6423906, Israel
08

References and documents

Individual participant data

Plan to share: Yes — a table summering pain assessing questioners will be available from corresponding author on reasonable request.

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2019; primary completion for Dec 2021, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Apr 30, 2018
StartEst.
Dec 2019
Primary completionEst.
Dec 2021
CompletionEst.
Dec 2021
Last update
Jun 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03511833
Collaborators
Medical Corps, Israel Defense Force
Responsible party
michal roll (Director, R&D Department, Tel-Aviv Sourasky Medical Center) — Principal investigator
First posted
Apr 30, 2018
Start date
Dec 2019 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jun 25, 2019

Study contacts

Pinchas Halpern, MD
Contact
DR_HALPERIN@tlvmc.gov.il
+97236973829
Daniel Trotzky, MD
Contact
danieltro@tlvmc.gov.il
+972507308675

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ketamine

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