Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

NCT04621110 | Unknown Phase 3

• 1 other identifier: Dexmedetomidine4040519
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Analgesia; Procedural Pain

Keywords

fentanyl; dexmedetomidine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Comparison if intranasal drugs has the same pain relief as intravenous drugs

  each 2 minutes up to 30 minutes

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

  each 2 minutes after medication up to 30 minutes

Study Arms (2)

intranasal dexmedetomidine and fentanyl

EXPERIMENTAL

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; Drug: intranasal fentanyl

intravenous ketamine and midazolam

ACTIVE COMPARATOR

ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs

Drug: intravenous ketamine (ketalar®); Drug: intravenous midazolam

Interventions

intranasal dexmedetomidine DRUG

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 dexmedetomidine and fentanyl

intranasal fentanyl DRUG

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)

intranasal dexmedetomidine and fentanyl

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 ketamine and midazolam

intravenous midazolam DRUG

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.

intravenous ketamine and midazolam

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

ITACI - Instituto de Tratamento do Câncer Infantil/ ICR HCFMUSP

São Paulo, 05410-030, Brazil

Location

Related Publications (8)

• 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.

  PMID: 27989326 BACKGROUND

• 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.

  PMID: 29364490 BACKGROUND

• 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.

  PMID: 26936022 BACKGROUND

• 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.

  PMID: 26323489 BACKGROUND

• 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.

  PMID: 28639236 BACKGROUND

• 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.

  PMID: 28781452 BACKGROUND

• 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.

  PMID: 30283188 BACKGROUND

• 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.

  PMID: 20956230 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Agnosia; Pain, Procedural

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Clarissa A Archanjo, M.D.

CONTACT

+5511964593842; clarissa.archanjo@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 9, 2020
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)