Postoperative Pain in Infants

NCT07856615 | Not Yet Recruiting

• 1 other identifier: Dnr 2026-01844-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate skin conductance measurement (SCM) for pain assessment in postoperative newborns. Pain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation Scale (N-PASS) in combination with physiological parameters. Skin conductance reflects sympathetic nervous system activity and provides a continuous, objective measure of stress and pain. This study will investigate the correlation between skin conductance measurements and standard clinical pain assessment tools (N-PASS and vital parameters), as well as explore the potential analgesic effect of skin-to-skin care on postoperative pain. The study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.

Conditions

Postoperative Pain

Keywords

skin conductance monitoring; postoperative pain; neonate; preterm infant

Outcome Measures

Primary Outcomes (1)

• Skin conductance to N-PASS score correlation

  Correlation between skin conductance measurements and N-PASS scores and vital parameters during the postoperative period

  72-80 hours after surgery

Eligibility Criteria

• Age: 22 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neonates receiving postoperative care in a tertiary neonatal intensive care unit.

You may qualify if:

• Neonates admitted to the NICU
• Undergoing surgical intervention
• Receiving postoperative care at the study site

You may not qualify if:

• Lack of parental consent (if applicable)
• Major congenital conditions affecting autonomic nervous system function

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative; Premature Birth

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)