- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02929524
Intranasal Ketamine as a Sedative for Venipuncture
October 7, 2016 updated by: Hospital de Clinicas de Porto Alegre
Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study
Randomized clinical trial, controlled, double-blind, parallel two-arm.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine group
This group was used intranasal ketamine, syringes were made with 4 ml of the drug (50mg/ml), 1 randomized per patient.
The validity stability and were 7 days after drawing the solution.
The drug began to take effect in 10 minutes and lasted about 40 minutes.
|
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:
|
Placebo Comparator: Placebo Group
This group was used intranasal saline, syringes were made with 4 ml of liquid 1 per patient randomized.
The validity stability and were 7 days after drawing the solution.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decreased venipuncture Time
Time Frame: Expected 3 minutes difference between the 2 groups
|
Expected 3 minutes difference between the 2 groups
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jefferson Piva, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
October 7, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 11, 2016
Study Record Updates
Last Update Posted (Estimate)
October 11, 2016
Last Update Submitted That Met QC Criteria
October 7, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Digestive System Diseases
- Acute Pain
- Respiratory Tract Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 150424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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