Comparison of intranasally given drug dexmedetomidine with N2O (=laughing gas) for sedation for small procedures in children's emergency department.

A prospective randomized open label study Intranasal dexmedetomidine versus inhaled nitrous oxide for children age 3 – 15 years for procedural sedation and analgesia in pediatric emergency department.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003773-17-SE

Enrollment

Unknown

Registered

2017-01-13

Start date

2017-06-12

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

sedation for emergency procedures

Interventions

Trade Name: Dexdor Pharmaceutical Form: Infusion Trade Name: Niontix Pharmaceutical Form: Inhalation vapour

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children at the age of 3 - 15 years who present to the emergency department • extremity fracture/luxation that require reduction or burn less than 4% of body surface area • Previously healthy (ASA I and II) • Swedish speaking Are the trial subjects under 18? yes Number of subjects for this age range: 156 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • ASA classification = III (see Supplement 11) • Current respiratory tract infection • Ear infection • Sinusitis • Pertussis within 6 months • Any symptoms of breathing difficulty • Active and uncontrolled vomiting • Impaired level of consciousness • Psychiatric issues • Hypersensitivity for dexmedetomidine or N2O. • Further contraindications named in the product resume for the trial medicines would categorize the patient as ASA III and therefore not suitable for this trial. o advanced heart block (grade 2 or 3) unless paced o uncontrolled hypotension o acute cerebrovascular conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: Aim of this study is to measure whether intranasal dexmedetomidine is equally good as nitrous oxide (N2O) among children between 3 and 15 years of age with minor injuries with respect to analgesia during procedure measured by FLACC in a prospective randomized open-label study. We are interested in finding out if dexmedetomidine could be used for PSA for painful procedures in combination with local anesthetics. ;Secondary Objective: not applicable;Primary end point(s): Primary outcome is pain during the procedure, pain during the procedure compared to the pain before. Pain will be assessed with FLACC27 (Face, Legs, Activity, Cry, Consolability scale);Timepoint(s) of evaluation of this end point: Pain (FLACC) assessment - at 0 – 5 – 10 min from administration of study medicine and continue every 5 minutes until Ramsay score 2 is reached - at the start of the procedure and every 5min under the procedure - after procedure every 10 minutes until the patient has recovered and reached Ramsay score 1	—

Measure

Time frame

Main Objective: Aim of this study is to measure whether intranasal dexmedetomidine is equally good as nitrous oxide (N2O) among children between 3 and 15 years of age with minor injuries with respect to analgesia during procedure measured by FLACC in a prospective randomized open-label study. We are interested in finding out if dexmedetomidine could be used for PSA for painful procedures in combination with local anesthetics. ;Secondary Objective: not applicable;Primary end point(s): Primary outcome is pain during the procedure, pain during the procedure compared to the pain before. Pain will be assessed with FLACC27 (Face, Legs, Activity, Cry, Consolability scale);Timepoint(s) of evaluation of this end point: Pain (FLACC) assessment - at 0 – 5 – 10 min from administration of study medicine and continue every 5 minutes until Ramsay score 2 is reached - at the start of the procedure and every 5min under the procedure - after procedure every 10 minutes until the patient has recovered and reached Ramsay score 1

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome is sedation, patient's/guardian's satisfaction and doctor's opinion about the feasibility of the procedure. Patient/guardian(s) will receive a questionnaire with few questions. Doctor's opinion will be recorded on the CRF. To assess the sedation Ramsay sedation scale will be used.;Timepoint(s) of evaluation of this end point: Sedation (Ramsay score) assessment - at 0 – 5 – 10 min from administration of study medicine and continue every 5 minutes until Ramsay score 2 is reached - at the start of the procedure and every 5min under the procedure - after procedure every 10 minutes until the patient has recovered and reached Ramsay score 1 Questionaries will be filled after the procedure.	—

Measure

Time frame

Secondary end point(s): The secondary outcome is sedation, patient's/guardian's satisfaction and doctor's opinion about the feasibility of the procedure. Patient/guardian(s) will receive a questionnaire with few questions. Doctor's opinion will be recorded on the CRF. To assess the sedation Ramsay sedation scale will be used.;Timepoint(s) of evaluation of this end point: Sedation (Ramsay score) assessment - at 0 – 5 – 10 min from administration of study medicine and continue every 5 minutes until Ramsay score 2 is reached - at the start of the procedure and every 5min under the procedure - after procedure every 10 minutes until the patient has recovered and reached Ramsay score 1 Questionaries will be filled after the procedure.

—

Countries

Sweden

Contacts

Public ContactAstrid Lindgrens Childrens hospital

Karolinska University Hospital

46851770000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026