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

Phase 2

Recruiting

• Conditions: Burns; Anaesthesiology - Pain management; Injuries and Accidents - Burns

• Registration Number: ACTRN12614000543684
• Lead Sponsor: Ix Biopharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) 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.

2) Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.

3) Agree to and be capable of understanding and signing an Informed Consent Form.

Exclusion Criteria

1) Cirrhosis or other evidence of clinically significant disorder in hepatic function, as determined by the Investigator.

2) Renal impairment as evidenced by estimated creatinine clearance (CrCL), from the Cockcroft-Gault method, of less than 30 mL/min.

3) 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.

4) History of hypersensitivity to ketamine or any of the excipients.

5) Suspected increased cerebrospinal fluid pressure.

6) Glaucoma.

7) Current (within the last six months) major affective disorder, as assessed by the Investigator.

8) Uncontrolled hyperthyroidism.

9) Acute intermittent porphyria.

10) Pregnant or breastfeeding women.

11) Participation in another clinical trial of an investigational agent within 30 days of entry into the present trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is Numerical rating scale (NSR) for pain intensity.[Timepoint: Baseline, and then at five minute intervals from commencement of dressing change until 20 minutes. ]