None listed
Conditions
Brief summary
This study aims ot assess the effectiveness of ketamine as an pain reliever when administered into the nasal passages in doses that do not produce sedation or anaesthesia in a group of adult emergency department patients coming to hospital with moderate to severe pain. We hypothesise that ketamine will reduce pain effectively without significant sedation at the proposed dose. A positive result may allow ketamine to be considered as an alternative pain reliever for acute pain in the emergency department that could be adminsitered through the nose and reduce the need for insertion of intravenous catheters in some patients suffering from moderate to severe pain.
Interventions
A single dose of intranasal ketamine (0.7mg/kg) will be administered to adult patients presenting to the emergency department with a verbal pain score of 6 or greater out of 10. A second dose of 0.5 mg/kg will be administered 15 minutes later if the patient requests further analgesia or there has not been an appreciable drop in pain score (greater than or equal to 3 out of 10)
An interim analysis will be undertaken after 30 patients to assess response to analgesia and/or presence of sedation. T
A single dose of intranasal ketamine (0.7mg/kg) will be administered to adult patients presenting to the emergency department with a verbal pain score of 6 or greater out of 10. A second dose of 0.5 mg/kg will be administered 15 minutes later if the patient requests further analgesia or there has not been an appreciable drop in pain score (greater than or equal to 3 out of 10) An interim analysis will be undertaken after 30 patients to assess response to analgesia and/or presence of sedation. The dose of ketamine will be adjusted up or down depending on response in these first 30 patients. If patients achieve significant fall in pain score ar 30 minutes and do not require rescue analgesia with parenteral opioids and do not show signs of sedation with the initial dosing regimen, this will be continued for the remaining numbers in the proposed cohort. If patients do not attain a drop in pain score of 3/10 or greater at 30 minutes with the initial dosing regimen, the initial dose of ketamine will be increased to 1 mg/kg for the remaining 120 patients. If the patients attain adequate analgesia (pain score fall greater than or equal to 3/10) but show signs of significant sedation, the initial dose of ketamine will be reduced to 0.5mg/kg for the remaning 120 patients.
Sponsors
Southern Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years of age Self-report pain severity as being greater than or equal to 6 on the standard 11-point verbal rating scale (0 = none, 10 = worst pain imaginable) Medical recommendation for parenteral analgesia (attending doctor’s discretion) Pain from any cause other than the 3 specific exclusions (see below)
Exclusion criteria
Known current pregnancy or patient suspects that might be pregnant at time of presentation or female of child-bearing age and not using any form of contraception.
Outcome results
None listed