Postoperative Pain in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Pain. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postoperative Pain Assessment in Newborns Using Skin Conductance Measurement
Overview
This observational study aims to evaluate skin conductance monitoring as a continuous method for pain assessment in postoperative neonates. 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. The study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.
Detailed description
Exposure to pain in the neonatal period is associated with adverse short- and long-term outcomes, including altered neurodevelopment. Accurate pain assessment is therefore essential but remains challenging due to the lack of a gold standard.
Currently, pain assessment in neonates relies on observational tools such as N-PASS, which incorporates behavioral and physiological indicators. However, these assessments are intermittent and subject to observer variability.
Skin conductance monitoring is an objective and continuous method that measures sympathetic nervous system activity through electrodermal responses. Previous research has demonstrated that skin conductance can detect stress and pain responses even in extremely preterm infants.
In this study, postoperative neonates admitted to the NICU will be continuously monitored using skin conductance for approximately 72-80 hours following surgery. Routine clinical pain assessments using N-PASS will be performed at regular intervals, alongside continuous monitoring of vital parameters.
Additional clinical data will be collected from electronic medical records, including demographic characteristics, perinatal history, surgical details, postoperative recovery parameters, and analgesic treatments.
The study is purely observational, and no interventions beyond standard clinical care will be introduced.
Primary outcome measures
- Skin conductance correlation to N-PASS [Time frame: 72-80 hours post surgery]
Eligibility criteria
Inclusion criteria
- Neonates admitted to the NICU
- Undergoing surgical intervention
- Receiving postoperative care at the study site
Exclusion criteria
- Major heart surgery
- No parental consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Sweden · 1 center
- Uppsala University Hospital — Uppsala
Identifiers
NCT: NCT07561047 · Dnr 2026-01844-01