Overview

This trial is active, not recruiting.

Conditions respiratory distress syndrome, prematurity of fetus
Treatments sedation by ketamine, sedation with midazolam
Phase phase 3
Sponsor University Hospital, Montpellier
Start date January 2012
End date May 2016
Trial size 62 participants
Trial identifier NCT01517828, 2011-003216-23, UF8736

Summary

Anesthesia is rarely used to intubate newborns in delivery room because of the very difficulty of accessing veins. The investigators hypothesized that intranasal administration of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used during neonates' intubation. They are also used intranasally in the absence of venous access-In a pilot study the investigators have demonstrated that sedation with Midazolam was effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4 (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.

The investigators hypothesized that intranasal ketamine would increase procedure effectiveness from 67 to 90%.

- Main objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.

- Secondary Objectives: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Phial of Ketamine (50mg/5ml) will be used and the dose administered will be 2 mg/kg.
sedation by ketamine
Kétamine (50mg/5ml, Panpharma): for a posology of 2 mg/kg: dose of 0.2 ml/kg Intranasal administration with a 1 ml syringe. Kétamine is a derivated of phencyclidine with a sedative, anesthesic, analgesic and amnesiant activity. Ketamine keeps also a protective reflex of upper respiratory tracts. One injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done.
(Active Comparator)
Phials of midazolam (5mg/5ml)will be used and the dose administered will be 0.2 ml/kg.
sedation with midazolam
Midazolam (phyal of 5mg/5ml, Mylan S.A.S.) for a posology of 0.2 mg/kg: dose of 0.2 ml/kg Instillation in intranasal with a syringe of 1 ml. Midazolam is an imidazobenzodiazépine, witj a sedative and hypnotic activity,anxiolytic, anti convulsive and muscle relaxant proprieties. One injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done.

Primary Outcomes

Measure
Newborns sedation quality
time frame: during the 10 minutes of intubation

Secondary Outcomes

Measure
intubation quality
time frame: during the 10 minutes of intubation
hemodynamic and respiratory tolerance
time frame: during 24 hours after intubation
neurological outcome at 2 years within the 2 groups
time frame: 2 years after the treatment

Eligibility Criteria

Male or female participants up to 2 hours old.

Inclusion Criteria: - Neonates in delivery room - Presence of respiratory distress syndrom requiring intubation (Silverman score> 3 and / or FiO2 greater than 30 % in premature infants under 30 weeks and over 40% after 30 weeks - Hemodynamic stability (mean arterial pressure> 3° percentile) Exclusion Criteria: - Need for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia) - Birth in the absence of an independent appraiser - Mother under general anesthesia

Additional Information

Official title Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room.
Principal investigator Christophe CM MILESI, MD
Description Randomized, double blind prospective multicenter study. Patients:-Inclusion criteria: (1) neonates in delivery room (2) Presence of repiratory distress syndrom requiring intubation (Silverman score> 3 and / or FiO2 greater than 30 % in premature infants under 30 weeks and over 40% after 30 weeks (3) hemodynamic stability (mean arterial pressure> 3° percentile) - Exclusion criteria: (1) Need for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia) (2) Birth in the absence of an independent appraiser (3) mother under general anesthesia. - Number of subjects required: 120 patients (60 per group) over a period of two years. This number was calculated to show a difference in sedation effectiveness from 67 to 90% with an alpha risk of 5% and a beta risk of 20%. - Study design: After obtaining parental consent, patients will be randomized in "Midazolam" arm or in "Ketamine" arm . Midazolam (0.2mg/kg = 0.2ml/kg) or Ketamine (2mg/kg = 0.2 ml/kg) are instilled in the nose, using a 1 ml syringe. The gesture will be directed by a physician having yet successfully completed a minimum of 50 intubations. After sedation completion, intubation decision will be taken at the onset of muscle relaxation or on the occurrence of apnea. - The clinical pain score will be evaluated on film a posteriori by two independent observers using a scale of hetero pain assessment.-Pain will be evaluated through the study of skin conductance. - The quality of intubation will be judged by the number of attempts required and by the duration of glottis exposure. - Hemodynamic and respiratory tolerances will be judged by measuring respectively variations in blood pressure, heart rate, FiO2 and the oxygen saturation. The neurological follow-up will be carried out according to Brunet-Lezine developmental scale at the age of 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.