RecruitingPhase 2ACTRN12614000543684

The analgesic efficacy, tolerability, safety and pharmacokinetics of a sublingual wafer formulation of ketamine in burns patients undergoing painful dressing changes


Sponsor

Ix Biopharma Pty Ltd

Enrollment

40 participants

Start Date

Apr 16, 2014

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Changing wound dressings for burn patients is a very painful experience, but the pain only lasts a short time. This study is testing a new form of pain relief — a ketamine wafer that dissolves under the tongue — to see if it can reduce pain during burn dressing changes compared to a placebo wafer. Ketamine has been used successfully in burns units for years and this new format could offer easier, needle-free pain relief. You may be eligible if: - You are between 18 and 65 years old - You are a burn patient who needs at least two dressing changes lasting at least 20 minutes each - Your dressing changes are expected to be painful enough to require pain relief - You are in generally good health without serious kidney, liver, heart, or breathing problems You may NOT be eligible if: - You have significant liver disease or cirrhosis - You have kidney impairment (creatinine clearance below 30 mL/min) - You have severe high blood pressure, heart failure, recent heart attack, or stroke - You have glaucoma or a history of increased pressure in the brain or spinal fluid - You have had a major mood disorder in the last 6 months - You are pregnant or breastfeeding - You have a known allergy to ketamine Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical 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

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)

Royal Perth Hospital - Perth

WA, Australia

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ACTRN12614000543684


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