None listed
Conditions
Brief summary
The most commonly employed paeidtric procedural analgosedatives (PAS) over the past few decades have been both nitrous oxide (N2O) and ketamine. This is a prospective randomised comparison trial comparing inhaled N2O plus INF to IV ketamine for paediatric patients requiring PAS for fracture reduction. We hypothesis that N2O plus INF is equivalent to ketamine regarding overall procedural analgosedative efficacy for the patient in addition to being more cost-effective given the quicker offset of action and consequent shorter length of stay plus the requirement for fewer and less specialised medical personnel.
Interventions
Nitrous oxide (N2O) plus intranasal fentanyl (INF) treatment group This treatment requires a Nurse Practitioner, Registrar or consultant physician. Patients randomised to this group will be given INF 2 µg/kg via laryngeal mask airway (LMA) Intranasal mucosal atomization device 15 mins prior to the procedure. Inhalation N2O will commence via a Matrix Digital mobile device management (MDM) delivery mixer starting at 50% N2O and titrated to a concentration of 70% N2O over 5 mins prior to procedure. This slow titration of N2O decreases the incidence of vomiting using N2O in combination with INF. Ketamine procedural sedation and analgesia (PSA) treatment group For the ketamine sedation a consultant physician, or registrar under the direction of a consultant physician, will be present at the bed side for the procedural sedation. Patients randomised to receive ketamine for PSA will receive an initial dose of 1 to 2 mg/kg IV Ketamine prior to commencement of the procedure. Dose of ketamine provided will be decided by clinician discretion. Topical EMLA (lidocaine 2.5% and prilocaine 2.5%) will be used at the site of injection at least 30 mins prior to IV cannulation to reduce pain at the injection site. Subsequent titrated doses of IV ketamine (0.3 to 0.5 mg/kg) may be administered during the procedure, as deemed necessary by the administering clinician.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria will comprise the following: patients aged 2 – 17 with closed limb or extremity fractures requiring reduction and manipulation.
Exclusion criteria
Exclusion criteria will be patients with multi-system trauma, head injury with altered level of consciousness or behavioural changes of known intolerance / severe allergy to fentanyl, N2O or ketamine.