Investigating Ketamine for treating the pain experienced by people bitten by a Red-Back Spider.
Investigating Ketamine for Red-Back Spider Envenoming (KuRED) - A Pilot Study
University of Newcastle
12 participants
Jan 9, 2017
Interventional
Conditions
Summary
AIMS To investigate the effectiveness of ketamine for the treatment of pain associated with red-back spider envenoming HYPOTHESES Ketamine will result in a significant change in the level of pain experienced by patients envenomed by red -back spider. RESEARCH DESIGN This pilot study will test the effectiveness of subanesthetic, intravenous ketamine infusions for red-back spider envenoming in a small single centre pilot trial. All patients will also receive standard opioid and nonopioid analgesia. Patients will be over 18 years old with moderate to severe red-back spider envenoming. The primary outcome will be clinically significant reduction in pain 30 minutes after administration of the ketamine infusion (compared to baseline). Informed written consent will be obtained from the patient using usual procedures prior to trial entry. All participants will receive analgesia according to a standardised protocol, commenced prior to administration of the trial drug. Patients will be cared for in an acute care area with physiological monitoring and if required intravenous parenteral analgesia as rescue medication. STUDY INTERVENTION A standard analgesia protocol will be followed prior to receiving the study intervention. The analgesia protocol will be as follows in all patients: paracetamol 1g orally PLUS oxycodone 10 mg orally. After the standard analgesia has been administered, the trial drug will be given to the patient. Subjects will be given an IV infusion with ketamine 15 mg in 100 mL of normal saline over 15 minutes. Clinical observations and patient pain score will be recorded at baseline and then post treatment at 30 minutes, one hour, two hours, four hours and on discharge. OUTCOMES: The primary outcome will be a clinically significant reduction in the severity of pain 30 min after the commencement of the ketamine infusion using the VNRS
Eligibility
Inclusion Criteria9
- A definite or likely red-back spider bite according to either of the following criteria:
- a. The spider causing the bite was clearly identified by the patient or clinician, OR
- b. A clinical syndrome consistent with typical red-back spider envenoming that is: the sensation of a bite followed by two or more of:
- increasing pain over the first hour
- radiating, regional or generalised pain
- local or regional diaphoresis
- AND
- The patient has significant enough pain that the treating clinician would normally treat the pain with standard analgesia.
- The syndrome of red-back spider envenoming used above is well defined and based upon a prospective study with formal identification of the responsible spiders.
Exclusion Criteria4
- Patients with pre-existing contraindications to study medication.
- Children aged <18.
- Presentation to hospital >36 hours after the bite.
- Pregnancy or breastfeeding.
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Interventions
A modified analgesia protocol will be followed prior to receiving the study intervention. The analgesia protocol will be as follows in all patients: paracetamol 1g orally PLUS oxycodone 10 mg orally. After this analgesia has been administered, the trial drug will be given to the patient. Patients with a history of a psychotic disorder, uncontrolled hypertension, ischaemic heart disease, tachyarrhythmia or pregnancy will not be included. Patients will be given one dose of IV-infusion with ketamine 15 mg in 100 mL of normal saline over 15 minutes. The patient will be continuously monitored (ECG, pulse oximetry and non-invasive blood pressure), after which they will be admitted to the Emergency Department Observation Ward/Short Stay Unit. Study observations will also be performed at 30min, 1h, 2h, and 4h after the trial drug and immediately prior to discharge if kept in hospital for longer than this. Length of hospital stay is variable depending on the clinical condition of individual patients, The first oral 50 mg ketamine lozenge will be given at 2 hours while the patient is in hospital and every 6 hours afterwards (4 lozenges in total). Therefore patients will be discharged on any of the remaining four ketamine lozenges. The patient will be given a sheet explaining when to take the lozenges and will be asked to record the times the treatment drug is taken as well as any other pain medication on a data sheet that will be collected by researchers. If the patient does not take all four doses of the trial medication, the remaining medication will also be returned to researchers. The patient will be contacted via phone by researchers at 24 and 48 hours.
Locations(1)
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ACTRN12616000889459