Intranasal Ketamine as a Sedative for Venipuncture

Ketamine

Brief Summary

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

Intervention / Treatment

  • 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
  • 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

Condition or Disease

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

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Months to 12 Years
    Enrollment: 39 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2015
    Primary Completion: Oct 01, 2016 ACTUAL
    Completion Date: Oct 01, 2016 ACTUAL
    Study First Posted: Oct 11, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 07, 2016

    Sponsors / Collaborators

    Lead Sponsor: Hospital de Clinicas de Porto Alegre
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Decreased venipuncture Time Expected 3 minutes difference between the 2 groups

    More Details

    NCT Number: NCT02929524
    Other IDs: 150424
    Study URL: https://clinicaltrials.gov/study/NCT02929524
    Last updated: Sep 29, 2023