NCT02929524

Intranasal Ketamine as a Sedative for Venipuncture

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-10-11
• Last updated: 2016-10-11