Intranasal Ketamine as a Sedative for Venipuncture

Phase 2

Completed

• Conditions: Respiratory Tract Disease; Acute Pain; Diseases of the Digestive System
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT02929524
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	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.
Ketamine group	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Decreased venipuncture Time	Expected 3 minutes difference between the 2 groups