Isfahan Alzahra Hospital Case Study
Methods and Materials
Study design and target group
This prospective double-blind clinical trial was conducted in the ED of Isfahan Alzahra Hospital, from May 2016 to June 2017. The sedation levels and different outcomes of patients receiving low-dose intravenous ketamine bolus (intervention group) were compared to patients receiving higher dosage of intravenous ketamine (control group), for reduction of upper and lower extremity fractures. Inclusion criteria consisted of parents' desire and consent to participate in the study, body mass index (BMI) within the normal range, having age of 6 months to 17 years, requiring a reduction of upper and lower limb fractures, not receiving benzodiazepines and other sedation drugs before intervention. …show more content…
Exclusion criteria consisted of patients' age (-- removed HTML --) 38 ̊C, due to upper respiratory tract infection. Patients having any other complications such as cardiovascular, gastrointestinal, psychological and neurological were excluded from the study. We also excluded patients with uncompleted data.
Participants and Intervention
The study flowchart is shown in figure 1. Two hundreds ten patients with a diagnosis of upper and lower extremity fractures, diagnosed by Emergency Medicine Specialist were enrolled, based on clinical and para-clinical images and inclusion criteria.
The participants were randomly allocated in two groups, using a block randomization procedure with matched subjects in each block based on sex and age. One hundred ninety eight patients completed the study; including one hundred from intervention group and 98 from control group. The study received ethics approval from the Ethics Committee of Isfahan University of Medical Sciences (--------------), and all participants and their parents signed the informed consent form.
After obtaining informed consent, eligible patients were enrolled. All patients were monitored by direct observation and continuous cardiovascular monitoring, in order to check the vital signs and also by pulse oximeters to examine the blood oxygen saturation level.
Tools and measures used for each patient during the process were as follows:
1- Recurrent suction and, if necessary, use of atropine to control excessive salivation
2- Laryngospasm and respiratory suppression and, airway management measures, in case of any complications
3- Controlling the heart rate and blood pressure, intracranial pressure (ICP) and performing sedation and using beta-blocker, if needed
4- Forecasting emergency response and providing a quiet and dark room and administrating midazolam, if needed
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Finally, after the intervention, the patients were put under close and direct observation in a quiet and dim room. The incidence of any side effects of ketamine injections such as gastrointestinal (nausea, vomiting, increase in salivary secretion), neurological (dizziness, headache, light-headedness, nystagmus, visual disturbance, drowsiness, numbness, or increased skeletal tone), psychological (hallucination, dysphoria or confusion, agitation, disorientation, or mood change) and cardiopulmonary (major: hypoxia and hypotension; minor: tachycardia and hypertension) were recorded by a Nurse, blinded to the intervention group; if necessary, immediate action was
taken.
Aldrete scoring system was used to assess the recovery and to determine the patient readiness for discharge. Wisconsin Sedation Scale and the Aldrete scoring system were calculated for each patient; if the Wisconsin sedation scale was >5 and the Aldrete scoring system >10, the patient was ready to discharge from the ED.
Data analysis
Only data from patients with completed information were analyzed and reported. Statistical analysis of data was performed using SPSS version 22 software. Chi-square test was used to compare qualitative variables between groups. Kolmogorov-Smirnov test was used, in order to evaluate the normal distribution of all quantitative studied parameters. Student t-test and paired t-test were used for variables with normal distribution. In addition, Mann-Whitney and Wilcoxon tests were used for variables without normal distribution. The two tailed p-value less than 0.05 were considered statistically significant.
Study design and target group
This prospective double-blind clinical trial was conducted in the ED of Isfahan Alzahra Hospital, from May 2016 to June 2017. The sedation levels and different outcomes of patients receiving low-dose intravenous ketamine bolus (intervention group) were compared to patients receiving higher dosage of intravenous ketamine (control group), for reduction of upper and lower extremity fractures. Inclusion criteria consisted of parents' desire and consent to participate in the study, body mass index (BMI) within the normal range, having age of 6 months to 17 years, requiring a reduction of upper and lower limb fractures, not receiving benzodiazepines and other sedation drugs before intervention. …show more content…
Exclusion criteria consisted of patients' age (-- removed HTML --) 38 ̊C, due to upper respiratory tract infection. Patients having any other complications such as cardiovascular, gastrointestinal, psychological and neurological were excluded from the study. We also excluded patients with uncompleted data.
Participants and Intervention
The study flowchart is shown in figure 1. Two hundreds ten patients with a diagnosis of upper and lower extremity fractures, diagnosed by Emergency Medicine Specialist were enrolled, based on clinical and para-clinical images and inclusion criteria.
The participants were randomly allocated in two groups, using a block randomization procedure with matched subjects in each block based on sex and age. One hundred ninety eight patients completed the study; including one hundred from intervention group and 98 from control group. The study received ethics approval from the Ethics Committee of Isfahan University of Medical Sciences (--------------), and all participants and their parents signed the informed consent form.
After obtaining informed consent, eligible patients were enrolled. All patients were monitored by direct observation and continuous cardiovascular monitoring, in order to check the vital signs and also by pulse oximeters to examine the blood oxygen saturation level.
Tools and measures used for each patient during the process were as follows:
1- Recurrent suction and, if necessary, use of atropine to control excessive salivation
2- Laryngospasm and respiratory suppression and, airway management measures, in case of any complications
3- Controlling the heart rate and blood pressure, intracranial pressure (ICP) and performing sedation and using beta-blocker, if needed
4- Forecasting emergency response and providing a quiet and dark room and administrating midazolam, if needed
In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Finally, after the intervention, the patients were put under close and direct observation in a quiet and dim room. The incidence of any side effects of ketamine injections such as gastrointestinal (nausea, vomiting, increase in salivary secretion), neurological (dizziness, headache, light-headedness, nystagmus, visual disturbance, drowsiness, numbness, or increased skeletal tone), psychological (hallucination, dysphoria or confusion, agitation, disorientation, or mood change) and cardiopulmonary (major: hypoxia and hypotension; minor: tachycardia and hypertension) were recorded by a Nurse, blinded to the intervention group; if necessary, immediate action was
taken.
Aldrete scoring system was used to assess the recovery and to determine the patient readiness for discharge. Wisconsin Sedation Scale and the Aldrete scoring system were calculated for each patient; if the Wisconsin sedation scale was >5 and the Aldrete scoring system >10, the patient was ready to discharge from the ED.
Data analysis
Only data from patients with completed information were analyzed and reported. Statistical analysis of data was performed using SPSS version 22 software. Chi-square test was used to compare qualitative variables between groups. Kolmogorov-Smirnov test was used, in order to evaluate the normal distribution of all quantitative studied parameters. Student t-test and paired t-test were used for variables with normal distribution. In addition, Mann-Whitney and Wilcoxon tests were used for variables without normal distribution. The two tailed p-value less than 0.05 were considered statistically significant.