Intranasal Ketamine as a Sedative for V… | Clinical Trial

Key information

Conditions

Respiratory Tract Disease Acute Pain Digestive System Diseases Diseases of the Digestive System Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Other names: Intervention group

Placebo

Drug

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

Other names: Saline group

Primary outcomes

Decreased venipuncture Time

Time frame: Expected 3 minutes difference between the 2 groups

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 11, 2016
Registry last updated: Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed