NCT04409665

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

The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST): a Randomized Study Comparing Intravenous Ketamine With Sublingual 30% Glucose

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 1 Minute – 4 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Neonatal Respiratory Distress Syndrome
• Gestational Age Conditions

Interventions

Type	Name	Description
DRUG	Ketamine	Patient will be sedated using Ketamine 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales
DRUG	Glucose	Patient will be sedated using Glucose 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-03-31
• Completion: 2022-04-30
• First posted: 2020-06-01
• Last updated: 2022-01-19

Locations

1 site across 1 country: Poland