Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain
Condition or Disease
- Acute Traumatic Pain
|Study results:||No Results Available|
|Age:||18 Years to 70 Years (Adult, Older Adult)|
Clinical Trial Dates
|Start date:||Dec 19, 2022|
|Primary Completion:||Dec 21, 2022|
|Completion Date:||Dec 21, 2022|
|Study First Posted:||Apr 30, 2018|
|Results First Posted:||Aug 31, 2020|
|Last Updated:||Jun 25, 2019|
Sponsors / Collaborators
- 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.
- Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
- The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
- 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.
- 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).
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
- Administration of the medication is limited to one hour from preparation in the syringe.
- 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.
- 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.
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.
- Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED.
- If the patient will be moved to another department from the ED, they will be withdrawn from the study.
- 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.
- 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.