Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room

NCT01517828 | Unknown Phase 3 DMC

• 2 other identifiers: UF87362011-003216-23
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Respiratory Distress Syndrome; Prematurity of Fetus

Keywords

Intubation; Delivery room; Sedation; Analgesia

Outcome Measures

Primary Outcomes (1)

• Newborns sedation quality

  The sedation quality of 2 newborns groups will be compared during the 10 minutes of intubation directly in delivery room and after on the film Pain evaluation done by a Specific clinical Score : the Faceless Acute Neonatal pain Scale (FANS) noted by two independent professional persons. And for Montpellier center, evaluation of pain by cutaneous conductance

  during the 10 minutes of intubation

Secondary Outcomes (3)

• intubation quality

  during the 10 minutes of intubation

• hemodynamic and respiratory tolerance

  during 24 hours after intubation

• neurological outcome at 2 years within the 2 groups

  2 years after the treatment

Study Arms (2)

Ketamine Arm

EXPERIMENTAL

Phial of Ketamine (50mg/5ml) will be used and the dose administered will be 2 mg/kg.

Drug: Sedation by ketamine

Midazolam Arm

ACTIVE COMPARATOR

Phials of midazolam (5mg/5ml)will be used and the dose administered will be 0.2 ml/kg.

Drug: Sedation with Midazolam

Interventions

Sedation by ketamine DRUG

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.

Ketamine Arm

Sedation with Midazolam DRUG

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.

Midazolam Arm

Eligibility Criteria

• Age: Up to 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

Centre Hospitalier Universitaire

Montpellier, 34000, France

Location

Centre Hospitalier Universitaire

Nîmes, 30000, France

Location

Centre Hospitalier Général

Perpignan, 66000, France

Location

Related Publications (1)

• Milesi C, Baleine J, Mura T, Benito-Castro F, Ferragu F, Thiriez G, Thevenot P, Combes C, Carbajal R, Cambonie G. Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3):F221-F226. doi: 10.1136/archdischild-2017-312808. Epub 2017 Aug 17.

  PMID: 28818854 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Agnosia

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christophe CM MILESI, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

FR (3)