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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings