The University of Cincinnati developed a two-page informed consent form that could be used in an emergency research study, involving the administration of pain medication to people who were in acute traumatic pain.
The following are a few sample items from that condensed form:
• Why is this research being performed? This research is being performed to study better ways of treating pain before getting to the hospital. The purpose of this research is to see if adding ketamine to standard pain medications improves pain control. The USAF is paying for this study.
• What is involved in the research study? You will receive a nasal spray that contains either ketamine or a salt solution. You will have a one out of two chance of receiving ketamine or the salt solution. You will be asked about your pain often, starting in about 30 minutes. You will be followed for up to 24 hours to see if you have any side effects. We may look at your medical records for information about your injury, treatment, and serious side effects.
• What are the risks of discomfort of the research study? The study drug ketamine can cause the following side effects:
- change in breathing patterns, blood pressure, or heart rate;
- nausea and/or vomiting;
- anxiousness, agitation, dizziness, dreamlike state, sleepiness, or confusion;
- double vision or involuntary eye movements;
- producing a lot of saliva in your mouth;
- auditory and/or visual hallucinations.
There may be unknown risks to you.
As with any new medication you are given, you may be allergic to the study medication and not know it. Allergic reactions can vary from a rash to reactions as extreme as death. You will not be enrolled in the study if the paramedics are aware you have a known allergy to morphine, fentanyl, or ketamine.
• Are there benefits to taking part in the research study? You may or may not have improved treatment of your pain.
• What compensation is available in case of injury? In the event that you become ill or injured from participating in this research study, emergency medical care will be provided to you. The University of Cincinnati will decide on a case-by-case basis whether to reimburse you for your out-of-pocket healthcare expenses.