Acute Pain, Diseases of the Digestive System, Respiratory Tract Disease
Conditions
Keywords
Ketamine, Intranasal administration, Pediatric nursing
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.
Interventions
DRUGKetamine
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
DRUGPlacebo
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
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreased venipuncture Time | Expected 3 minutes difference between the 2 groups |
Outcome results
None listed