Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

Study Overview
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Brief Summary
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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.

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

Conditions
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Pediatric Cancer, Analgesia, Procedural Pain

Intervention / Treatment
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* Drug: intranasal dexmedetomidine
* Drug: intranasal fentanyl
* Drug: intravenous ketamine (ketalar®)
* Drug: intravenous midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intranasal dexmedetomidine and fentanyl<br>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<br>* 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.<br>Drug: intranasal fentanyl<br>* 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)<br>|
| Active Comparator: intravenous ketamine and midazolam<br>ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs | Drug: intravenous ketamine (ketalar®)<br>* 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.<br>Drug: intravenous midazolam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The FLACC scale will be measure each 2 minutes up to 30 minutes. | 
| 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 | The Ramsay scale will be measure each 2 minutes up to 30 minutes. | 
| 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%. | each 2 minutes up to 30 minutes | 
| 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%. | each 2 minutes up to 30 minutes | 
| 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%. | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, dexmedetomidine