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 paediatric 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. The data from this study will be used to calculate sample size and design a study comparing the effective dose of ketamine to other pain relivers currently administered by the nasal route to children.
Interventions
A single dose of intranasal ketamine (0.7mg/kg) will be administered to children aged 3 to 13 years and less than 50kg in weight, presenting to the emergency department with a musculoskeletal injury and 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 analysis will be undertaken after 30 patient
A single dose of intranasal ketamine (0.7mg/kg) will be administered to children aged 3 to 13 years and less than 50kg in weight, presenting to the emergency department with a musculoskeletal injury and 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 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 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 and admnistered to another 30 patients. Data will then be analysed for this dose. OR 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 second 30 patients followed by analysis of the data for this second cohort of patients. The second dose of ketamine at t=15 minutes (if required) will remain at 0.5mg/kg
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
3 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
Children aged three to 13 years and under 50kg body weight Musculoskeletal injury to upper and/or lower limbs Visual analog pain score greater than or equal to 6/10 on the standard 11-point verbal rating scale (0 = none, 10 = worst pain imaginable) and patient would normally be considered for intranasal fentanyl administration. Use of simple analgesia such as paracetamol or ibuprofen or inhalational methoxyflurane during ambulance transport are not exclusion criteria
Exclusion criteria
Inability to gain informed consent from parent or guardian Prior administration of parenteral or intranasal analgesics (morphine, fentanyl) Prior administration of oral opioid analgesia (oxycodone, codeine) Allergy to ketamine Aberrant nasal anatomy Acute or chronic nasal problems or nasal trauma that may preclude adequate administration or absorption of intranasal medication. Presence of multiple trauma or injuries. Sustained a head injury with loss of consciousness. Presence of cognitive impairment.
Outcome results
None listed