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
Overview
- Phase
- Phase 1
- Intervention
- Ketamine
- Conditions
- Neonatal Respiratory Distress Syndrome
- Sponsor
- Medical University of Warsaw
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Assessment of patient sedation
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
PAWEL KRAJEWSKI, MD
Head of the division of neonatology
Medical University of Warsaw
Eligibility Criteria
Inclusion Criteria
- •Infant with established Respiratory Distress Syndrome (RDS) or at risk for RDS
- •Gestational age 28 0/7 - 32 6/7 weeks
- •Non-invasive respiratory support with nasal CPAP (incl. BiPAP) or NIPPV
- •Need for administration of exogenous surfactant
Exclusion Criteria
- •Need for intubation and mechanical ventilation at the Delivery Room
- •Infant with clinically significant maxillo-facial, tracheal or pulmonary malformations
Arms & Interventions
Ketamine sedated group
30 randomized patients will receive Ketamine 1 mg/kg , I.V. 2 minutes before LISA
Intervention: Ketamine
Glucose sedated group
30 patients will receive Glucose 30% 1 mL, sublingually, 2 minutes before LISA
Intervention: Glucose
Outcomes
Primary Outcomes
Assessment of patient sedation
Time Frame: First assessment 10 minutes before procedure, second during the procedure
Assessment of patient sedation change before and after LISA using FANS scale
Comparing ketamine and glucose
Time Frame: Comparing the scores through study completion, an average of two years
Comparison of the effectiveness of sedation with ketamine and glucose using the COMFORT scale scores. The Comfort scale ranges from 8 points at minimum, to 40 at maximum. The higher the score, the lower the sedation level.
Secondary Outcomes
- Frequency of complications(During the procedure)