Back to resultsIntranasal Ketamine as a Sedative for Venipuncture
Primary Purpose
Respiratory Tract Disease, Acute Pain, Diseases of the Digestive System
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Disease focused on measuring Ketamine, Intranasal administration, Pediatric nursing
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine group
Placebo Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Decreased venipuncture Time
Secondary Outcome Measures
Full Information
NCT ID
NCT02929524
First Posted
October 7, 2016
Last Updated
October 7, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02929524
Brief Title
Intranasal Ketamine as a Sedative for Venipuncture
Official Title
Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Disease, Acute Pain, Diseases of the Digestive System
Keywords
Ketamine, Intranasal administration, Pediatric nursing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Intervention group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline group
Intervention Description
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
Primary Outcome Measure Information:
Title
Decreased venipuncture Time
Time Frame
Expected 3 minutes difference between the 2 groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson Piva
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intranasal Ketamine as a Sedative for Venipuncture
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