NCT04621110

Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2020-11-09
• Last updated: 2021-04-01

Locations

1 site across 1 country: Brazil