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AzTrials

Pediatric CancerPhase 3NAIVeNCT04621110

Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

A Phase 3 study testing intranasal dexmedetomidine, intranasal fentanyl and intravenous ketamine (ketalar®) in people with Pediatric Cancer and Analgesia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 8 years
Conditions the study is for
Pediatric Cancer, Analgesia, Procedural Pain
What is being tested?
intranasal dexmedetomidine, intranasal fentanyl and intravenous ketamine (ketalar®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
1 Jun 2021to Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Clarissa A Archanjo, M.D. contact

+5511964593842

clarissa.archanjo@yahoo.com.br

Brazil1 site

  • ITACI - Instituto de Tratamento do Câncer Infantil/ ICR HCFMUSP

    São Paulo, 05410-030

    Clarissa A Archanjo, M.D., +5511964593842, clarissa.archanjo@yahoo.com.br

Other trials in Brazil

About this study

Official title: 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.

Being tested
intranasal dexmedetomidine, intranasal fentanyl, intravenous ketamine (ketalar®), intravenous midazolam
Keywords
fentanyl, dexmedetomidine
Medical subject headings
Neoplasms, Agnosia, Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intranasal dexmedetomidineDrug

    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.

  • intranasal fentanylDrug

    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)

  • intravenous ketamine (ketalar®)Drug

    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.

  • intravenous midazolamDrug

    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.

Study groups in NCT04621110
Study groupRoleWhat they receive
intranasal dexmedetomidine and fentanylExperimentalDexmedetomidine (precedex®) and fentanyl will be administered by intranasal routes, seeing if both sedative (dexmedetomidine) and analgesic (fentanyl) can give enough sedation for procedure
Receives: Drug: intranasal dexmedetomidine; Drug: intranasal fentanyl
intravenous ketamine and midazolamActive comparatorketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs
Receives: Drug: intravenous ketamine (ketalar®); Drug: intravenous midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain control

    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

    Measured: The FLACC scale will be measure each 2 minutes up to 30 minutes.

  2. Sedation

    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

    Measured: The Ramsay scale will be measure each 2 minutes up to 30 minutes.

  3. Change in heart rate

    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%.

    Measured: each 2 minutes up to 30 minutes

  4. Change in respiratory rate

    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%.

    Measured: each 2 minutes up to 30 minutes

  5. Change in blood pressure

    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%.

    Measured: each 2 minutes up to 30 minutes

Secondary outcomes (2)

  1. Comparison if intranasal drugs has the same pain relief as intravenous drugs

    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

    Measured: each 2 minutes up to 30 minutes

  2. Comparison if intranasal drugs has the same sedation effects like intravenous drug

    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.

    Measured: each 2 minutes after medication up to 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start1 Jun 2021 (estimated)
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621110
Sponsor's protocol ID
Dexmedetomidine4040519
Acronym
NAIVe
Status last verified
Mar 2021
First submitted
29 Sep 2020
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manworren RC, Stinson J. Pediatric Pain Measurement, Assessment, and Evaluation. Semin Pediatr Neurol. 2016 Aug;23(3):189-200. doi: 10.1016/j.spen.2016.10.001. Epub 2016 Oct 17.

    PubMed 27989326

  • Fantacci C, Fabrizio GC, Ferrara P, Franceschi F, Chiaretti A. Intranasal drug administration for procedural sedation in children admitted to pediatric Emergency Room. Eur Rev Med Pharmacol Sci. 2018 Jan;22(1):217-222. doi: 10.26355/eurrev_201801_14120.

    PubMed 29364490

  • Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.

    PubMed 26936022

  • Tug A, Hanci A, Turk HS, Aybey F, Isil CT, Sayin P, Oba S. Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging Sedation. Paediatr Drugs. 2015 Dec;17(6):479-85. doi: 10.1007/s40272-015-0145-1.

    PubMed 26323489

  • Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.

    PubMed 28639236

  • Gupta A, Dalvi NP, Tendolkar BA. Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients: A prospective randomized double blind trial. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):236-240. doi: 10.4103/joacp.JOACP_204_16.

    PubMed 28781452

  • Chatrath V, Kumar R, Sachdeva U, Thakur M. Intranasal Fentanyl, Midazolam and Dexmedetomidine as Premedication in Pediatric Patients. Anesth Essays Res. 2018 Jul-Sep;12(3):748-753. doi: 10.4103/aer.AER_97_18.

    PubMed 30283188

  • Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL. Part 14: pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S876-908. doi: 10.1161/CIRCULATIONAHA.110.971101. No abstract available.

    PubMed 20956230

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing intranasal dexmedetomidine, intranasal fentanyl and intravenous ketamine (ketalar®) in people with Pediatric Cancer and Analgesia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clarissa A Archanjo, M.D. (+5511964593842, clarissa.archanjo@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain control (time frame: The FLACC scale will be measure each 2 minutes up to 30 minutes.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04621110, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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