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.
Condition or Disease
- Neonatal Respiratory Distress Syndrome
- Gestational Age Conditions
Phase
Study Design
Study type: | Interventional |
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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 | |
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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 |
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This clinical trial is recruiting
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More Details
NCT Number: | NCT04409665 |
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Acronym: | LISA KGS |
Other IDs: | LISA KGS TRIAL 2020 |
Study URL: | https://ClinicalTrials.gov/show/NCT04409665 |
Last updated: Jun 17, 2022