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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02929524
Other study ID # 150424
Secondary ID
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


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
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