None listed
Conditions
Brief summary
Fentanyl is a pain-relieving agent that is commonly used to provide short term analgesia for painful procedures. This study aims to compare the effectiveness of two concentrations of intranasal fentanyl (INF) in children aged between 3 and 15 years presenting to the Emergency Department with clinically fractured long bones (arms or legs). These patients will be given either a highly concentrated solution or a standard concentration. Their pain scores and other observations will be recorded before they are given INF and at 10, 20 and 30 minutes after.
Interventions
Fentanyl is an opiate analgeisa used for relief of strong pain. Total dosage for both groups is the same; ie 1.5 mics/kg, however the concentration for the intervention group will be 50micrograms/ml and for the control group will be 300micrograms/ml. The dose will be administered and then repeated according to effect after 10minutes. If requied may have 2-3 doses during study period. Study period is 30 minutes after which time child's care will be taken over by usual medical and nursing staff. A
Fentanyl is an opiate analgeisa used for relief of strong pain. Total dosage for both groups is the same; ie 1.5 mics/kg, however the concentration for the intervention group will be 50micrograms/ml and for the control group will be 300micrograms/ml. The dose will be administered and then repeated according to effect after 10minutes. If requied may have 2-3 doses during study period. Study period is 30 minutes after which time child's care will be taken over by usual medical and nursing staff. Administration of fentnayl takes seconds. Observation time is 30 minutes. Drug is administered intranasally
Sponsors
Princess Margaret Hospital for Children (PMH)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
3 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Children aged 3 to 15 years presenting to the emergency department with clinically deformed closed long bone fractures would be included.
Exclusion criteria
Administration of an opiate analgesic (excluding codeine) within 4 hours of arrival in ED, Head injury resulting in impaired judgement, Known allergies to opiate analgesics, Significantly blocked or traumatised nose preventing nasal administration, Inability to perform pain scoring, Compound fracture
Outcome results
None listed