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

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ClinicalTrials.gov Identifier: NCT04621110
Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Eduardo Juan Troster, University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE September 29, 2020
First Posted Date  ICMJE November 9, 2020
Last Update Posted Date April 1, 2021
Estimated Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2020)
  • 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
  • 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
  • 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%.
  • 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%.
  • 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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2020)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants
Official Title  ICMJE Intranasal Dexmedetomidine and Fentanyl Versus Intravenous Midazolam and Ketamine in Sedation for Painful Outpatient Procedures
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediatric Cancer
  • Analgesia
  • Procedural Pain
Intervention  ICMJE
  • 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)
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: intranasal dexmedetomidine
    • Drug: intranasal fentanyl
  • Active Comparator: intravenous ketamine and midazolam
    ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs
    Interventions:
    • Drug: intravenous ketamine (ketalar®)
    • Drug: intravenous midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clarissa A Archanjo, M.D. +5511964593842 clarissa.archanjo@yahoo.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04621110
Other Study ID Numbers  ICMJE Dexmedetomidine4040519
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eduardo Juan Troster, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo General Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP