Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures (INDEXER)

Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures: Randomized Double-blinded Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anesthesia
• Intervention / Treatment: Drug: Intranasal Drug; Drug: Intranasal Drug

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Outi Peltoniemi; Phone Number: +35883155837; Email: outi.peltoniemi@ppshp.fi

Study Locations

• Finland
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Outi Peltoniemi; Phone Number: +35883155837; Email: outi.peltoniemi@ppshp.fi
    • Contact: Miikka Tervonen; Phone Number: +35883158428; Email: miikka.tervonen@ppshp.fi
    • Principal Investigator: Outi Peltoniemi
    • Sub-Investigator: Miikka Tervonen
    • Sub-Investigator: Terhi Tapiainen
    • Sub-Investigator: Merja Kallio
    • Sub-Investigator: Niko Paalanne
    • Sub-Investigator: Ulla Koskela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; 1µg/kg intranasal dexmedetomidine	Drug: Intranasal Drug; 1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture; Other Names: Dexmedetomidine; Drug: Intranasal Drug; Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture; Other Names: Placebo
Placebo Comparator: Placebo; 0,01ml/kg intranasal 4,5% saline	Drug: Intranasal Drug; 1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture; Other Names: Dexmedetomidine; Drug: Intranasal Drug; Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After the first attempt of the procedure. The procedure is attempted 30 minutes after the study drug administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of the procedure	The duration of the procedure	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.
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.	Parents return a questionnaire within 2 hours after the study drug has been administered.
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.	The numerical value of VAS is asked in the end of the follow up period of 2 hours.
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.	Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
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.	Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
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.	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.
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	The follow up period lasts 2 hours from the study drug administration.
Blood pressure	The systolic, diastolic and mean blood pressures are measured by manometer in every 5 minutes.	Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Respiratory rate	Respiratory rate is assessed by capnometry continuously and the rate is documented in every 5 minutes.	Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Oxygen saturation	Oxygen saturation is measured by pulse oxymetry continuously and the rate is documented in every 5 minutes	Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Heart rate	Heart rate is measured by ECG continuously and the rate is documented in every 5 minutes	Every 5 minutes from 15 minutes prior the study drug to 2 hours after the administration of the drug.
Attempts needed to complete the procedure	The number attempts needed to complete the procedure is recorded.	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.

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Principal Investigator: Outi Peltoniemi, Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; pediatric; children; dexmedetomidine; sedation; intranasal dexmedetomidine; emergency room sedation; intranasal sedation; pediatric sedation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: INDEXER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No