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

Analgesia Clinical Trial

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

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04621110
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Clarissa A Archanjo, M.D.
Phone +5511964593842
Email clarissa.archanjo@yahoo.com.br
Status Not yet recruiting
Phase Phase 3
Start date June 1, 2021
Completion date December 2021
View Details
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