Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
|ClinicalTrials.gov Identifier: NCT01538745|
Recruitment Status : Unknown
Verified January 2013 by Joshua Miller, Brooke Army Medical Center.
Recruitment status was: Recruiting
First Posted : February 24, 2012
Last Update Posted : January 29, 2013
The purpose of this study is to compare the safety and effectiveness of intravenous low dose ketamine to the industry standard of morphine in regards to controlling acute pain in the emergency department.
Both LDK and morphine have side effects. The amount and character of these side effects will be compared. Additionally, the degree of sedation or agitation will be specifically measured. The aim of this current study is to make this comparison and shift the evidence for LDK use from the anecdotal to the scientific.
|Condition or disease||Intervention/treatment||Phase|
|Abdomen, Acute Other Acute Pain Flank Pain, Acute Back Pain, Acute Extremity Pain, Acute||Drug: Ketamine Drug: Morphine||Phase 4|
Phase 1 is a randomized, controlled, double-blinded study comparing the use of low-dose ketamine (LDK) to morphine for acute pain control in emergency department patients. A convenience sample of subjects will be enrolled from a population of patients aged 18-50 who present to the Brooke Army Medical Center Emergency Department with acute abdominal pain, flank/lumbar back pain and/or pain to the extremities. To take part in the study, a need for opioid analgesia must be indicated by the treating physician in addition to the patient meeting all other study criteria.
The patient will then be randomized into one of the two treatment arms. Prior to receiving either the study medication (ketamine) or the active control (morphine) the patient will be asked to rate their pain on a numeric rating scale (NRS) with 0 being no pain and 10 being the worst pain possible. Their baseline vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) will also be documented. These vital signs and the NRS will be reassessed at 5, 10 and 20 minutes post medication dosage. At 20 minutes they will also document a Richmond Agitation Sedation Scale (RASS) score and will ask the patient if they require additional pain medication. If the patient denies the need for a second dose of medication they will continue to be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing.
If at any time during the study the patient requires a second dose of pain medication, following the administration of the med, they will be assessed for vital signs at 5,10 and 20 minutes after the dose. At 20 minutes, a RASS score and NRS score will also be documented. They will then be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing.
If they require a third dose of pain medication at any time during the study, this is considered a treatment failure and the treating physician will be contacted to provide any further pain control.
The second phase of the study will be observational. An anonymous satisfaction survey will be provided to the treating nurse, physician/PA of the patients recruited from part one of the study. The purpose of conducting the survey is so that an observation point of view can be added to the data to provide a measure of how well the patient's pain was controlled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||September 2013|
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.
0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Other Name: Ketalar
Active Comparator: Morphine
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.
0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
- Maximal change in NRS pain score as a percentage of initial NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes post dose ]Evaluation of the maximal change in patient's pain (based on their numerical rating scale score) throughout the study versus their initial pain rating prior to drug administration.
- Time to change in NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes ]Following dosage with study medication, the amount of time in increments of 20 minutes taken to demonstrate a change in the patient's NRS pain score.
- Time to maximal change in NRS pain score [ Time Frame: every 20 minutes to a total of 120 minutes ]Following dosage with study medication, the amount of time in increments of 20 minutes taken to demonstrate the maximal change in the patient's NRS pain score.
- Duration of maximal change in NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes ]Maximal change in NRS pain score is to be defined as the largest change from patient's baseline pain score. Duration of maximal change is how long the patient's pain score remained at this level.
- Incidence of treatment failure [ Time Frame: 120 minutes ]Requiring more than two doses of the study medication provided for adequate pain control
- Incidence of side effects, including outlying vital signs [ Time Frame: 20,40,60,80,100,120 minutes ]The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), Numerical Rating Score (NRS) and Richmond Agitation Sedation Scale (RASS) score at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. All side effects and outlying vital signs will be documented.
- Maximum deviation from 0 on the Richmond Agitation Sedation Scale (RASS) [ Time Frame: 20,40,60,80,100,120 minutes ]Using 0 as the "normal/baseline" on the RASS, maximal deviation in either direction will be used to demonstrate the effect of the study medications on levels of sedation or agitation.
- Nurse and physician satisfaction scores [ Time Frame: 120 minutes after start of study ]The patient's treating nurses and physicians/PAs will be given a survey to evaluate the level of pain control they believe the patient achieved.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538745
|Contact: Victoria J Ganem, BSNfirstname.lastname@example.org|
|United States, Texas|
|Brooke Army Medical Center||Recruiting|
|San Antonio, Texas, United States, 78234|
|Contact: Victoria J Ganem, BSN 210-916-0808 email@example.com|
|Principal Investigator: Joshua P Miller, MD|
|Sub-Investigator: Steven Schauer, DO|
|Sub-Investigator: Vikhyat Bebarta, MD|
|Principal Investigator:||Joshua P Miller, MD||United States Air Force|