Intranasal Ketamine as a Sedative for Venipuncture

NCT02929524 | Completed Phase 2

• 1 other identifier: 150424
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized clinical trial, controlled, double-blind, parallel two-arm.

Conditions

Respiratory Tract Disease; Acute Pain; Diseases of the Digestive System

Keywords

Ketamine; Intranasal administration; Pediatric nursing

Outcome Measures

Primary Outcomes (1)

• Decreased venipuncture Time

  Expected 3 minutes difference between the 2 groups

Study Arms (2)

Ketamine group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Ketamine DRUG

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

Also known as: Intervention group

Ketamine group

Placebo DRUG

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

Also known as: Saline group

Placebo Group

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
• Aged 3 months to 12 years;
• Requiring venipuncture independent research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Respiratory Tract Diseases; Acute Pain; Digestive System Diseases

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jefferson Piva

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10