NCT01517828

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

Status unknown Phase 3 Last updated 2 December 2014

What this trial tests

Phase 3 trial testing Sedation by ketamine in Respiratory Distress Syndrome in 62 participants. Status unknown.

Timeline

1 January 2012

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	62
Start date	1 January 2012
Primary completion	1 May 2016
Estimated completion	1 May 2016
Sites	3 locations across France

Drugs / interventions tested

• Sedation by ketamine — full drug profile →
• Sedation with Midazolam — full drug profile →

Conditions studied

• Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →
• Prematurity of Fetus — all drugs for Prematurity of Fetus →

Sponsor

University Hospital, Montpellier

Who can join

Under 2 Hours, any sex, with Respiratory Distress Syndrome or Prematurity of Fetus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Newborns sedation quality
  Time frame: during the 10 minutes of intubation
  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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial.
   Milési C, Baleine J, Mura T, Benito-Castro F, et al · · 2018 · cited 22× · PMID 28818854 · DOI 10.1136/archdischild-2017-312808