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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 3

Conditions: Analgesia; Pediatric Cancer; Procedural Pain

Treatments: Drug: intranasal fentanyl; Drug: intravenous ketamine (ketalar®); Drug: intranasal dexmedetomidine; Drug: intravenous midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT04621110

Dexmedetomidine4040519

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

intranasal dexmedetomidine and fentanyl

Experimental group

Description:

Dexmedetomidine (precedex®) and fentanyl will be administered by intranasal routes, seeing if both sedative (dexmedetomidine) and analgesic (fentanyl) can give enough sedation for procedure

Treatment:

Drug: intranasal fentanyl

Drug: intranasal dexmedetomidine

intravenous ketamine and midazolam

Active Comparator group

Description:

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

Treatment:

Drug: intravenous ketamine (ketalar®)

Drug: intravenous midazolam