Back to resultsIntranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures (INDEXER)
Primary Purpose
Pain, Anesthesia
Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Intranasal Drug
Intranasal Drug
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring pediatrics, sedation, emergency room sedation, intranasal sedation, dexmedetomidine, intranasal dexmedetomidine, children, pediatric, pediatric sedation
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
Exclusion Criteria:
- Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
- II or III degree AV-blockage without pacemaker
- Uncontrollable hypotension
- Stroke
- Critically ill patients who are admitted to the PICU
- Patients with clear cardiac or respiratory dysfunction
- Lowered level of consciousness
- Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
- A single patient can only take part in this study once.
Sites / Locations
- Oulu University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Placebo
Arm Description
1µg/kg intranasal dexmedetomidine
0,01ml/kg intranasal 4,5% saline
Outcomes
Primary Outcome Measures
Success of the procedure
The success of the first attempt of the procedure (venous cannulation or lumbar puncture) is evaluated at the end of the first attempt of the procedure. Succesfulness of venous cannulation is tested by the doctor on call by flushing the cannula with saline. If the cannula works without complications the cannulation is successfull. Lumbar puncture is successfull if all the samples needed from the liquor are collected.
Secondary Outcome Measures
The duration of the procedure
The duration of the procedure
Parents assessment of the patients pain during the procedure
Parents assessment of the patients pain during the procedure on a visual analog scale. Parents fill in a questionnaire after the procedure is done. Questionnaire is returned to the research doctor during the follow up period.
Patient pain VAS
Patients assessment of the experienced pain with Visual Analog Scale is asked in the end of the follow up period. Visual Analog Scale is a numerical value for the pain experienced by the patient ranging from 0 to 10.
Patient pain FLACC
Assessment of pain levels of the patient with FLACC-scores. Assessment is done by the study doctor. FLACC is abbreviation of Faces Legs Activity Crying and Consolability scale. FLACC ranges from 0 to 10 as 0 being no pain at all and 10 being the most pain possible.
Patient sedation level
Assessment of sedation levels of the patient with Comfort-B-scores. Assessment is done by the study doctor.Comfort-B is a sedation scale ranging from 6 to 30. The lower the score the more sedated a patient is.
Duration of crying
Duration of the patients crying during and after the procedure. The duration of crying associated with the procedure is recorded in seconds and minutes.
Effectivity of the drug
The parents are asked in the end of the follow up period whether they think the patient received the experimental drug or placebo
Blood pressure
The systolic, diastolic and mean blood pressures are measured by manometer in every 5 minutes.
Respiratory rate
Respiratory rate is assessed by capnometry continuously and the rate is documented in every 5 minutes.
Oxygen saturation
Oxygen saturation is measured by pulse oxymetry continuously and the rate is documented in every 5 minutes
Heart rate
Heart rate is measured by ECG continuously and the rate is documented in every 5 minutes
Attempts needed to complete the procedure
The number attempts needed to complete the procedure is recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03564093
Brief Title
Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures
Acronym
INDEXER
Official Title
Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anesthesia
Keywords
pediatrics, sedation, emergency room sedation, intranasal sedation, dexmedetomidine, intranasal dexmedetomidine, children, pediatric, pediatric sedation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
1µg/kg intranasal dexmedetomidine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0,01ml/kg intranasal 4,5% saline
Intervention Type
Drug
Intervention Name(s)
Intranasal Drug
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture
Intervention Type
Drug
Intervention Name(s)
Intranasal Drug
Other Intervention Name(s)
Placebo
Intervention Description
Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture
Primary Outcome Measure Information:
Title
Success of the procedure
Description
The success of the first attempt of the procedure (venous cannulation or lumbar puncture) is evaluated at the end of the first attempt of the procedure. Succesfulness of venous cannulation is tested by the doctor on call by flushing the cannula with saline. If the cannula works without complications the cannulation is successfull. Lumbar puncture is successfull if all the samples needed from the liquor are collected.
Time Frame
After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.
Secondary Outcome Measure Information:
Title
The duration of the procedure
Description
The duration of the procedure
Time Frame
The time from the start of the first attempt of the procedure to the success of the procedure. The procedure is attempted 30 after the study drug administration. Time from the first needle puncture to ending the procedure is recorded.
Title
Parents assessment of the patients pain during the procedure
Description
Parents assessment of the patients pain during the procedure on a visual analog scale. Parents fill in a questionnaire after the procedure is done. Questionnaire is returned to the research doctor during the follow up period.
Time Frame
Parents return a questionnaire within 2 hours after the study drug has been administered.
Title
Patient pain VAS
Description
Patients assessment of the experienced pain with Visual Analog Scale is asked in the end of the follow up period. Visual Analog Scale is a numerical value for the pain experienced by the patient ranging from 0 to 10.
Time Frame
The numerical value of VAS is asked in the end of the follow up period of 2 hours.
Title
Patient pain FLACC
Description
Assessment of pain levels of the patient with FLACC-scores. Assessment is done by the study doctor. FLACC is abbreviation of Faces Legs Activity Crying and Consolability scale. FLACC ranges from 0 to 10 as 0 being no pain at all and 10 being the most pain possible.
Time Frame
Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Title
Patient sedation level
Description
Assessment of sedation levels of the patient with Comfort-B-scores. Assessment is done by the study doctor.Comfort-B is a sedation scale ranging from 6 to 30. The lower the score the more sedated a patient is.
Time Frame
Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Title
Duration of crying
Description
Duration of the patients crying during and after the procedure. The duration of crying associated with the procedure is recorded in seconds and minutes.
Time Frame
Duration of crying during the time period from 25 minutes after the study drug administration for 30 minute time period in which the procedure is anticipated to be done.
Title
Effectivity of the drug
Description
The parents are asked in the end of the follow up period whether they think the patient received the experimental drug or placebo
Time Frame
The follow up period lasts 2 hours from the study drug administration.
Title
Blood pressure
Description
The systolic, diastolic and mean blood pressures are measured by manometer in every 5 minutes.
Time Frame
Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Title
Respiratory rate
Description
Respiratory rate is assessed by capnometry continuously and the rate is documented in every 5 minutes.
Time Frame
Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Title
Oxygen saturation
Description
Oxygen saturation is measured by pulse oxymetry continuously and the rate is documented in every 5 minutes
Time Frame
Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Title
Heart rate
Description
Heart rate is measured by ECG continuously and the rate is documented in every 5 minutes
Time Frame
Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Title
Attempts needed to complete the procedure
Description
The number attempts needed to complete the procedure is recorded.
Time Frame
After the successful attempt of the procedure. The first attempt of the procedure is done 30 minutes after the study drug administration. The assessment is done within 2 hours of the administration of the study drug.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
Exclusion Criteria:
Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
II or III degree AV-blockage without pacemaker
Uncontrollable hypotension
Stroke
Critically ill patients who are admitted to the PICU
Patients with clear cardiac or respiratory dysfunction
Lowered level of consciousness
Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
A single patient can only take part in this study once.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Outi Peltoniemi
Phone
+35883155837
Email
outi.peltoniemi@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Outi Peltoniemi
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Outi Peltoniemi
Phone
+35883155837
Email
outi.peltoniemi@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Miikka Tervonen
Phone
+35883158428
Email
miikka.tervonen@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Outi Peltoniemi
First Name & Middle Initial & Last Name & Degree
Miikka Tervonen
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen
First Name & Middle Initial & Last Name & Degree
Merja Kallio
First Name & Middle Initial & Last Name & Degree
Niko Paalanne
First Name & Middle Initial & Last Name & Degree
Ulla Koskela
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures
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