Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain
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|ClinicalTrials.gov Identifier: NCT03511833|
Recruitment Status : Not yet recruiting
First Posted : April 30, 2018
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Traumatic Pain||Drug: Morphine Drug: Ketamine||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Morphine group
Morphine group will receive IV medication and IN saline.
IV morphine -0.1 mg/kg: Morphine vial contains 10 mg/10 ml = 1mg/ml ----> 0.1 ml/kg
Other Name: no other Intervention name
Experimental: Ketamine group
Ketamine group will receive IV saline and IN medication.
IN ketamine: 1 mg/kg: Ketamine vial contains 100 mg/2 ml = 50mg/ml ---> 0.02ml/kg
Other Name: no other Intervention name
- Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 2 hour post administration [ Time Frame: 2 hours ]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.
- • adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 2 hour post administration ] [ Time Frame: 2 hours ]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.
- • patient satisfaction [Interview] [ Time Frame: 2 hours post administration ] [ Time Frame: 2 hours post administration ]patients were asked to provide subjective comments
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511833
|Contact: Pinchas Halpern, MD||+97236973829||DR_HALPERIN@tlvmc.gov.il|
|Contact: Daniel Trotzky, MDemail@example.com|
|Tel Aviv Sourasky Medical Center, department of Emergency Medicine||Not yet recruiting|
|Tel Aviv, Israel, 6423906|
|Contact: Pinchas Halpern, MD 972-3-6973829 firstname.lastname@example.org|
|Contact: Daniel Trotzky, MD +972507308675 email@example.com|
|Principal Investigator: Pinchas Halpern, MD|