Intranasal Ketamine as a Sedative for Venipuncture

Acute Pain Clinical Trial

Official title:

Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929524
• Other study ID #: 150424
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 7, 2016
• Last updated: October 7, 2016
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Randomized clinical trial, controlled, double-blind, parallel two-arm.

Description:

Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Years

Eligibility

Inclusion Criteria:

• Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;

• Aged 3 months to 12 years;

• Requiring venipuncture independent research.

Exclusion Criteria:

• Severe neurological sequelae;

• Patients who need immediate venipuncture at risk;

• Presence of active nosebleeds;

• Patients using drugs sedative and analgesic continuos;

• Children who have experienced clinical change with ketamine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Digestive System Diseases
• Diseases of the Digestive System
• Respiratory Tract Disease
• Respiratory Tract Diseases

Intervention

Drug:
• Ketamine
As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions
• Placebo
As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased venipuncture Time		Expected 3 minutes difference between the 2 groups	No