Clinical trial NCT02489630
Conditions: Acute Pain Pain
Sponsor: Carilion Clinic
Start date: 2013-09-01; Completion date: 2015-03-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the use of low doses of ketamine, along with opiate pain medication, is more effective at controlling the acute pain of patients in the emergency department than opiate pain medication alone. In addition, this study examines whether patients treated with low doses of ketamine, along with opiate pain medication, will require less opiate pain medication to control their pain, and whether these patients are equally happy with their pain control as patients who receive only opiate pain medication.

Detailed description:
This randomized, double blinded, placebo controlled study investigates the use of low-dose ketamine, in conjunction to standard opiate treatment, as compared to placebo plus standard opiate treatment, for acute painful conditions in the ED setting. The investigators hypothesize that patients treated with ketamine will require less opiate for similar levels of pain relief up to 2 hours from initiation of treatment, with similar levels of patient satisfaction and an acceptable side effect profile.

Once seen by a physician, potential patients will receive provider-determined opiate treatment for their painful condition, prior to the informed consent process to ensure that treatment is not delayed. Once identified for inclusion, patients will receive informed consent and, upon consent, will subsequently be randomized through block randomization into one of two study groups. Each study group will contain at least 50 subjects. Randomization will be determined using a table of random numbers, using a restricted randomization scheme to ensure roughly equal numbers in each group. Group assignments will be sealed in opaque envelopes to be opened sequentially by the investigators. Group assignments will not indicate whether it is the treatment or the control group. At this time (T0), an initial NRS-11 score will be obtained. The NRS-11 is an 11-point scale on which patients rate their level of pain from 0 ("no pain") to 10 ("worst pain imaginable"). If, after initial analgesic, pain level is \<6, patients will be asked again in 15 min. If at this time it is still \<6, they will not proceed in the study. The intervention group will receive 0.1 mg/kg of ketamine given over 1 minute, and the control group will receive an equivalent volume of normal saline; both groups will have received a provider-determined dose of opiate analgesia prior to enrollment. At thirty-minute intervals, subjects will be asked their level of pain, if they need more pain control and will be evaluated for the presence of side effects (hallucinations, dysphoria, weakness, diplopia, nausea, vomiting, dizziness, itching and bradypnea) as well as sedation as defined by Ramsay score of greater than 2. Repeat doses of pain medication will be given as 0.05 mg/kg morphine or equivalent dose of opioid analgesic. Total opiate dosage and number of repeat doses given at the end of 120 minutes will be recorded. At each time interval, as well as at the end of 120 minutes (T120), patient satisfaction with pain control will be recoded on the 4-point Likert scale, with 0 being "completely unsatisfied" and 3 being "very satisfied".

Arms: arm 1: 0.1 mg/kg ketamine + opiate analgesic arm 2: 0.1 mL/kg normal saline + opiate analgesic
Interventions: intervention 1: Ketamine intervention 2: Normal Saline intervention 3: opiate analgesic
Intervention descriptions: intervention 1: 0.1mg/kg ketamine IV intervention 2: 1ml/kg normal saline placebo intervention 3: 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request

Protocol documents:
Prot_000.pdf: 
 
Low Dose Ketamine as an Adjunct to Opiates 
for Acute Pain in the Emergency Department 
 
 
 
Corey Heitz, MD 
 
 
NCT02489630  
 
August 30, 2015  
 


Study Protocol 
 
 


 
 


 


 


 


 
 


 
 

SAP_001.pdf: 
Low Dose Ketamine as an Adjunct to Opiates 
for Acute Pain in the Emergency Department 
 
 
 
Corey Heitz, MD 
 
 
NCT02489630  
 
 
August 30, 2015 
 
 


Statistical Analysis Plan: 
Data will be recorded regarding patients’ chief complaint/painful condition, number of prior visits 
for painful conditions, prior opioid use, initial pain level (as reported using the NRS‐1116), pain level 
throughout the study (collected at 30‐minute intervals), satisfaction with their pain control 
(collected at 30‐minute intervals, beginning at T30), requirement for repeat doses of opioid 
analgesic, total amount of opioid given, vital signs (blood pressure, heart rate, respiratory rate, and 
oxygen saturation determined by pulse oximetry), sedation level (measured by the Ramsay 
scale18), any side effects experienced, age, race, sex, and other (nonopioid) medications/doses. 
The study is powered for analysis using two‐sided independent sample t tests, requiring a randomized 
sample size of 110 to provide 80% power to detect, independently a difference of 1.5 on the NRS‐11 
scale and/or a difference of 0.5 on the 4‐point Likert scale.  
The comparison of treatment groups across patient demographics and opioid usage will be 
implemented using Wilcoxon rank sum tests, chi‐squared tests, and Fisher's exact test when cell sizes 
are small. Pain and satisfaction scores will be compared across treatment groups using linear mixed 
models as a function of treatment, time, and their interaction and with a random intercept. Upon visual 
inspection of the plotted pain level curves, a cubic time component will be implemented for pain level 
scores due to the expected curvature of the scores across time. All statistical analysis was performed in 
SAS (version 9, SAS Institute Inc.).