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Premedication for preventing pain in infants undergoing non-urgent breathing tube placement

Effectiveness of fentanyl and atropine for premedication of the newborn infant before non-emergency endotracheal intubation: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13875422
Enrollment
80
Registered
2022-10-12
Start date
2017-06-30
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premedication for non-urgent endotracheal intubation for preventing pain in neonates with respiratory failure Respiratory

Interventions

The research team comprised three research neonatologists, a child health care expert, and three assistants with extensive research and clinical experience. Following the acquisition of informed conse

Sponsors

Children’s Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children with indications for endotracheal intubation, intravenous access or time to open intravenous access, and able to complete intubation within 15-30 minutes

Exclusion criteria

Exclusion criteria: 1. Children with emergency intubation 2. Structural abnormalities of the upper respiratory tract (e.g. Pierre-Robin syndrome, glottic stenosis) 3. Upper digestive tract malformation (such as diaphragmatic hernia) 4. A history of difficulty in endotracheal intubation 5. Central respiratory failure caused by asphyxia or brain injury 6. Children intubated twice or more during treatment

Design outcomes

Primary

MeasureTime frame
1. Behavioural responses measured using the N-PASS score at the time of intubation 2. Analgesic efficacy measured using plasma neuron-specific enolase (NSE), cortisol and endorphins concentrations in venous blood samples before and after intubation

Secondary

MeasureTime frame
1. Conditions of endotracheal intubation (difficulty of intubation, the opening and closing state of the glottis, and the children's response to intubation) evaluated using the modified Goldberg score at the time of intubation 2. Adverse reactions evaluated using heart rate (HR), oxygen saturation (SaO2) and regional cerebral oxygen saturation (rScO2) before and after intubation

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026