Intranasal Ketamine as a Sedative for Venipuncture

Study Overview
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Brief Summary
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Randomized clinical trial, controlled, double-blind, parallel two-arm.

Detailed Description
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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.

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

Conditions
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Respiratory Tract Disease, Acute Pain, Diseases of the Digestive System

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine group<br>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. | Drug: Ketamine<br>* 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<br>* Other names: Intervention group;|
| Placebo Comparator: Placebo Group<br>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. | Drug: Placebo<br>* 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<br>* Other names: Saline group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased venipuncture Time |  | Expected 3 minutes difference between the 2 groups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Intranasal administration, Pediatric nursing