Objective measurement of behavioural parameters of pain in infants

Recruiting

• Conditions: pijn 1) tijdens vaccinatie en 2) na chirurgische ingrepen; discomfort; pain

• Registration Number: NL-OMON29904
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1st part of the study:
- the neonate/baby has a gestational age of at least 36 weeks.
2nd part of the study:
- Neonates and infants aged 0-18 months
- Weight > 1500 grams
- Abdominal, including urological, or thoracic surgery

Exclusion Criteria

1st part of study:
- exclusion criteria for a vaccination will be followed.
2nd part of the study:
- Receiving sedative drugs or muscle relaxants < 12 hours prior to surgery
- Receiving sedative drugs or muscle relaxants after surgery
- Neurological damage (posthypoxic encephalopathy or major congenital anomalies of the central nervous system)
- (Severe) spasticity
- Hypotonia
- Corrected gestational age < 36 weeks

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measures are the muscle activity of the corrugator<br /><br>supercilii and the orbicularis oculii, either during a painful event or during<br /><br>prolonged pain in infants at the NICU. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>During the 1st part of the study only the Neonatal Facial Coding System.<br /><br>During the 2nd part of the study the Neonatal Facial Coding System and the<br /><br>movement of the extremities and heart rate.</p><br>