The analgesic efficacy, tolerability, safety and pharmacokinetics of a sublingual wafer formulation of ketamine in burns patients undergoing painful dressing changes
Ix Biopharma Pty Ltd
40 participants
Apr 16, 2014
Interventional
Conditions
Summary
The change of dressing in burns patients is a painful procedure; however, the pain is only short-lasting. Therefore pain relief requires a fast, but short acting method. Options widely used are inhalation of Entonox (a pain relieving gas mixture), short acting morphine-like tablets or administration of morphine-like drugs by patient-controlled analgesia pumps. In Royal Perth Hospital ketamine, a short-acting pain killer has been used successfully via patient controlled analgesia pumps for many years and, since the Bali disaster, by use of administration under the tongue (as liquid or lozenge made by hospital pharmacy). A new preparation of ketamine as a wafer, to be administered under the tongue, has been shown to have a rapid onset of effect with minimal adverse effects in volunteers. This could be a promising way to provide pain relief for dressing changes without the need for an intravenous line and with minimal adverse effects. The new medication will be tried in in-patients of the burns unit requiring painful dressing changes. The medication will be compared to placebo wafers, but patients can at any time ask for rescue analgesia, which will include the methods mentioned above. It is expected that ketamine wafers provide better analgesia than placebo with less need for rescue analgesia than placebo. The results of this trial will permit further development of this promising new form of pain relief.
Eligibility
Inclusion Criteria3
- Adult burn patients aged 18-65 years requiring at least two anticipated dressing changes of likely duration at least 20 minutes and anticipated to be sufficiently painful that procedural analgesia is clinically indicated.
- Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
- Agree to and be capable of understanding and signing an Informed Consent Form.
Exclusion Criteria11
- Cirrhosis or other evidence of clinically significant disorder in hepatic function, as determined by the Investigator.
- Renal impairment as evidenced by estimated creatinine clearance (CrCL), from the Cockcroft-Gault method, of less than 30 mL/min.
- Any condition in which a significant elevation of blood pressure would be hazardous, e.g. severe cardiovascular disease, heart failure, severe or poorly controlled hypertension, recent myocardial infarction, current stroke or cerebral trauma, intracerebral mass or haemorrhage.
- History of hypersensitivity to ketamine or any of the excipients.
- Suspected increased cerebrospinal fluid pressure.
- Glaucoma.
- Current (within the last six months) major affective disorder, as assessed by the Investigator.
- Uncontrolled hyperthyroidism.
- Acute intermittent porphyria.
- Pregnant or breastfeeding women.
- Participation in another clinical trial of an investigational agent within 30 days of entry into the present trial.
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Interventions
Each patient will be dosed on two occasions, dressing change one and two, with a single dose of two 25mg racemic ketamine wafers or a single dose of two placebo wafers sublingually. The two treatment occasions will be separated by a minimum wash out period of 24 hours. The sequence of the two treatments will be randomly assigned.
Locations(1)
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ACTRN12614000543684