The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST)

Brief Summary

The purpose of this study is to evaluate the efficacy and impact of intravenous ketamine or sublingual 30% glucose as sedation drugs used in preterm premature babies during the LISA procedure. The second goal is to compare the frequency of complications during LISA with both premedication regimens.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Glucose

Condition or Disease

  • Neonatal Respiratory Distress Syndrome
  • Gestational Age Conditions

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: up to 4 Months   (Child)
Enrollment: 60 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 01, 2020
Primary Completion: Dec 31, 2021
Completion Date: Dec 31, 2021
Study First Posted: Jun 01, 2020
Results First Posted: Aug 31, 2020
Last Updated: Jun 01, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

All infants fulfilling the inclusion criteria during the 12 months recruitment window will potentially be enrolled in this randomized controlled trial of LISA premedication. Written informed consent will be acquired from parents or legal guardians. After the consent, infants needing the LISA will receive premedication as follows: caffeine citrate according to the clinical routine at study site, and randomly, either ketamine or sublingual glucose 30%. This study is a pilot study and 60 patients that will be randomized 1:1. Ketamine will be given in slow intravenous injection over 60 seconds. Glucose 30% will be given sublingually in the volume of 1 mL. After two minutes (from the end of administration of the study drug or reference drug), laryngoscopy will be started. To assess the effectiveness of both types of sedation, patients will be assessed using two pain assessment scales - the COMFORT scale and the FANS scale. 10 minutes before the procedure, the first assessment in the COMFORT and FANS scales will take place. The next assessment on both scales will take place during the procedure.

Eligibility Criteria

Sex: All

This clinical trial is recruiting

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More Details

NCT Number: NCT04409665
Acronym: LISA KGS
Other IDs: LISA KGS TRIAL 2020
Study URL: https://ClinicalTrials.gov/show/NCT04409665
Last updated: Jun 17, 2022