Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants (NAIVe)

March 30, 2021 updated by: Eduardo Juan Troster, University of Sao Paulo General Hospital

Intranasal Dexmedetomidine and Fentanyl Versus Intravenous Midazolam and Ketamine in Sedation for Painful Outpatient Procedures

Pain is a vital sign that depends on personal experience involving different factors such as previous sensory and emotional experience, age, spiritual and cultural aspects, that makes it harder to evaluate, especially in young children. Pain control is important to diminish the anxiety of the child and family, also this is more important in patients who require procedure and treatment that are more painful, like oncological and hematological patients. The study aims to measure if the intranasal drugs (dexmedetomidine and fentanyl) has the same outcomes when compared with intravenous drug (ketamine and midazolam), but with less side effects. The participants are patients from an oncologic outpatient, that will be submitted to cerebrospinal fluid puncture, myelogram or both will be randomized assigned to both groups. The study will compare physiological variables ( heart rate, respiratory rate and blood pressure) and sedation and pain scales to see if its work properly. The study purpose is to evaluate if intranasal drug works in the same way with less side effects comparing with the usual treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 05410-030
        • ITACI - Instituto de Tratamento do Câncer Infantil/ ICR HCFMUSP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with oncohematological diseases that requires cerebrospinal fluid, myelogram or both for staging and monitoring their treatment ( leukemia, lymphoma, solid tumors and bone marrow aplasia)
  • Patients who is undergoing to collect cerebrospinal fluid, myelogram or both;
  • aged between two and eight years;
  • absence of tumor recurrence.

Exclusion Criteria:

  • Previous neurologic disease;
  • Using of opioid previously;
  • Neurological developmental delay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intranasal dexmedetomidine and fentanyl
Dexmedetomidine (precedex®) and fentanyl will be administered by intranasal routes, seeing if both sedative (dexmedetomidine) and analgesic (fentanyl) can give enough sedation for procedure
Drug: intranasal dexmedetomidine
Dexmedetomidine (precedex®) will be administered by intranasal route in 1ug/kg each dose, repeating at most 3 times to see if it can give enough sedation to painful procedure. To assess the level of sedation the study will use Ramsay sedation scale.
Drug: intranasal fentanyl
Fentanyl will be administered by intranasal route in 1,5ug/kg each dose, repeating at most 3 times to see if it can give enough pain relief for painful procedure. To assess pain control the study will use Face, Legs, Activity, Cry, Consolability scale ( FLACC)
Active Comparator: intravenous ketamine and midazolam
ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs
Drug: intravenous ketamine (ketalar®)
Ketamine (ketalar®) will be administrated by intravenous route in 1mg/kg dose and the study will use this drug to compare the efficiency of intranasal drugs.
Drug: intravenous midazolam
Midazolam will be administrated by intravenous route in 0,1mg/kg dose and the study will use this drug to compare the efficiency of intranasal drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain control
Time Frame: The FLACC scale will be measure each 2 minutes up to 30 minutes.
Evaluate if intranasal drugs is effective for pain relief in painful procedures for paediatric oncologic and hematologic patients. To measure it will use Face, Legs, Activity, Cry, Consolability scale (FLACC). This is a scale for pain in children, and for each sign gives 0-2 point, and 0 is no pain and 7-10 intense pain
The FLACC scale will be measure each 2 minutes up to 30 minutes.
Sedation
Time Frame: The Ramsay scale will be measure each 2 minutes up to 30 minutes.
Evaluate if intranasal drugs is effective for sedation in painful procedures for paediatric oncologic and hematologic patients. For access this, will be use Ramsay scale, this scale range between 1 to 6. 1 is a anxious patient and 6 sleeping patient without answer
The Ramsay scale will be measure each 2 minutes up to 30 minutes.
Change in heart rate
Time Frame: each 2 minutes up to 30 minutes
evaluate side effects using PALS ( paediatric advanced life support) values for ages. To evaluate this, heart rate values will be noted before the procedure, during and after that and will be evaluated if there was an increase or decrease in it, respecting a significance level of 5%.
each 2 minutes up to 30 minutes
Change in respiratory rate
Time Frame: each 2 minutes up to 30 minutes
evaluate side effects using PALS ( paediatric advanced life support) values for different ages. To evaluate this, respiratory rate values will be noted before the procedure, during and after that and will be evaluated if there was an increase or decrease in it, respecting a significance level of 5%.
each 2 minutes up to 30 minutes
Change in blood pressure
Time Frame: each 2 minutes up to 30 minutes
evaluate side effects using PALS ( paediatric advanced life support) values for ages. To evaluate this, blood pressure value will be noted before the procedure, during and after that and will be evaluated if there was an increase or decrease in it, respecting a significance level of 5%.
each 2 minutes up to 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison if intranasal drugs has the same pain relief as intravenous drugs
Time Frame: each 2 minutes up to 30 minutes
Using Face, Legs, Activity, Cry, Consolability (FLACC) to compare both arms. The FLACC is a scale for pain in children, and for each sign gives 0-2 point, and 0 is no pain and 7-10 intense pain
each 2 minutes up to 30 minutes
Comparison if intranasal drugs has the same sedation effects like intravenous drug
Time Frame: each 2 minutes after medication up to 30 minutes
Using Ramsay scale to compare both arms, intranasal and intravenous drugs. The Ramsay scale range between 1 to 6. 1 is a anxious patient and 6 sleeping patient without answer effect in sedation.
each 2 minutes after medication up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexmedetomidine4040519

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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