Ketamine dose finding study in pediatric burn wound care

Ketamine dose finding study in pediatric burn wound care - KEDOB

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002012-27-SE

Enrollment

Registered

2013-09-19

Start date

2013-10-30

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Pediatric burn patients who need rectal sedation during wound care

Interventions

Product Name: Ketamine Pharmaceutical Form: Intravesical solution/solution for injection INN or Proposed INN: KETAMINE HYDROCHLORIDE CAS Number: 1867-66-9 Current Sponsor code: N/A Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Children aged 0.5-4 years and weighing over 7 kg and below 38 kg. • Burns requiring sedation at least three occasions after written consent could be obtained. • Written consent from the child's guardian or legal representative • Swedish-speaking parents alt. interpreter on site • Fasting from food at least 6 hours, breast milk 4 hours and clear liquids 2 hours before initiation of sedation Are the trial subjects under 18? yes Number of subjects for this age range: 60 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: •Rectal / anal pathology • Children who require intensive care for their burns (continuous sedation and respiratory needs) • Treatment or illness that according to the investigator may affect the treatment or study results • Participation in another clinical trial • Previous participation in this study. • Known / suspected allergy or contraindication * against any product included in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to compare the effects of three different doses of rectally administrated Ketamine in pediatric burn wound care;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is pain/anxiety Secondary variables are the presence of side effects, recovery time, acceptance of treatment and sedation level. Safety variables are saturation, respiratory and heart rate, blood pressure and documentation of AE and SAE reporting. What is considered an AE is defined in the study protocol ;Timepoint(s) of evaluation of this end point: Primary endpoint; Before, during and after sedation/wound care.	—

Measure

Time frame

Main Objective: The objective of this study is to compare the effects of three different doses of rectally administrated Ketamine in pediatric burn wound care;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is pain/anxiety Secondary variables are the presence of side effects, recovery time, acceptance of treatment and sedation level. Safety variables are saturation, respiratory and heart rate, blood pressure and documentation of AE and SAE reporting. What is considered an AE is defined in the study protocol ;Timepoint(s) of evaluation of this end point: Primary endpoint; Before, during and after sedation/wound care.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints; during and after sedation ;Timepoint(s) of evaluation of this end point: Safety variables (vital signs) are evaluted every fifth minute.	—

Countries

Sweden

Contacts

Public ContactBrännskademottagningen

LANDSTINGET I ÖSTERGÖTLAND

folke.sjoberg@lio.se+460101031820

Outcome results

None listed

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