Comparison of intranasally given drug dexmedetomidine with intranasal S-keramine for sedation for small procedures in children's emergency department.

A prospective randomized double-blind study Intranasal dexmedetomidine versus intranasal S-ketamine for children age 1 – 3 years for procedural sedation and analgesia in pediatric emergency department.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000057-40-SE

Enrollment

Registered

2017-01-13

Start date

2017-06-12

Completion date

Unknown

Last updated

2024-03-18

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: Ketanest Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children at the age of 1 - 3 years who present to the emergency department - A laceration in need of suturing or burn less than 4% of body surface area - Weight 10 – 15 kg - Previously healthy - Swedish speaking Are the trial subjects under 18? yes Number of subjects for this age range: 52 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 12) •Current respiratory tract infection •Impaired level of consciousness •Hypersensitivity for dexmedetomidine or S-ketamine. •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. - advanced heart block (grade 2 or 3) unless paced - uncontrolled hypotension - acute cerebrovascular conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to measure whether intranasal dexmedetomidine can provide better, faster onset of action and more effective, analgesia and sedation during procedure than intranasal S-ketamine among children between 1 and 3 years of age with minor injuries with respect to analgesia measured by FLACC in a prospective randomized doubleblind study. We are interested in finding out if intranasal dexmedetomidine could be used for PSA for painful procedures in combination with local anesthesia.;Secondary Objective: not applicable;Primary end point(s): Primary outcome is pain during the procedure, pain during the procedure compared to the pain before sedation. Pain will be assessed by trained ED nurses with FLACC (Face, Legs, Activity, Cry, Consolability) scale and change of 2 points on the scale of 0-10 is considered as significant change.;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: The aim of this study is to measure whether intranasal dexmedetomidine can provide better, faster onset of action and more effective, analgesia and sedation during procedure than intranasal S-ketamine among children between 1 and 3 years of age with minor injuries with respect to analgesia measured by FLACC in a prospective randomized doubleblind study. We are interested in finding out if intranasal dexmedetomidine could be used for PSA for painful procedures in combination with local anesthesia.;Secondary Objective: not applicable;Primary end point(s): Primary outcome is pain during the procedure, pain during the procedure compared to the pain before sedation. Pain will be assessed by trained ED nurses with FLACC (Face, Legs, Activity, Cry, Consolability) scale and change of 2 points on the scale of 0-10 is considered as significant change.;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

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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 scale20 will be used. A change of 1 point on the scale of 1-6 is considered as significant change.;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 scale20 will be used. A change of 1 point on the scale of 1-6 is considered as significant change.;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.

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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