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Ketamine versus nitrous oxide plus intranasal fentanyl for paediatric fracture reduction in the emergency department: a prospective randomised comparison trial

Ketamine versus nitrous oxide plus intranasal fentanyl for paediatric fracture reduction in the emergency department: a prospective randomised comparison trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000555156
Enrollment
216
Registered
2019-04-09
Start date
2019-09-02
Completion date
2021-03-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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

David Bishop
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to 17 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026