Neonatal Pain Management and Pain Monitoring Using New Methods

Pain, Acute Clinical Trial

Official title:

Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967118
• Other study ID #: 296/2018
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Oulu
• Contact: Anna-Kaija Palomaa
• Phone: +358400892159
• Email: annakaija.palomaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure.

The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 42 Weeks

Eligibility

Inclusion Criteria:

• Gestational Age (GA) at birth 32+0 - 42+0

• Admitted to NICU

• Parents are able to read, write and speak Finnish

Exclusion Criteria:

• With a postnatal age of 14 days or more

• Apgar points were 6 or less at 5 minutes of age

• Has been found grade III or IV cerebral haemorrhage

• Major congenital anomalies

• Has intubated or receiving a nCPAP

• Has received analgesics or sedatives for less than 24 hours prior to the study

Related Conditions & MeSH terms

• Acute Pain
• Infant
• Pain, Acute
• Pain, Procedural
• Procedural Pain

Intervention

Behavioral:
• Skin-to-skin contact
Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
• Mother's heartbeats as sound and vibration
The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.

Drug:
• 30% oral glucose
The infant will be given 30% oral glucose solution 2 minutes before the injection

Locations

Country	Name	City	State
Finland	Oulu University Hospita	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale	Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.	Baseline 1, measured pre-intervention
Primary	Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale	Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.	Baseline 2, measured pre-procedure
Primary	Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale	Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.	Measured during painful procedure
Primary	Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale	Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.	Measured immediately after painful procedure
Primary	Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.	Baseline 1, measured pre-intervention
Primary	Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.	Baseline 2, measured pre-procedure
Primary	Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.	Measured during painful procedure
Primary	Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.	Measured immediately after painful procedure
Primary	Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)	In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.	Baseline 1, measured pre-intervention
Primary	Change in the activation in the somatosensory cortical areas following the noxious stimulation	In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.	Baseline 2, measured pre-procedure
Primary	Change of the activation in the somatosensory cortical areas following the noxious stimulation	In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.	Measured during painful procedure
Primary	Change of the activation in the somatosensory cortical areas following the noxious stimulation	In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.	Measured immediately after painful procedure
Primary	Change in heart rate (HR)	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.	Baseline 1, measured pre-intervention
Primary	Change in heart rate (HR)	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.	Baseline 2, measured pre-procedure
Primary	Change in heart rate (HR)	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.	Measured during painful procedure
Primary	Change in heart rate (HR)	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.	Measured immediately after procedure
Primary	Change in oxygen saturation	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.	Baseline 1, measured pre-intervention
Primary	Change in oxygen saturation	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.	Baseline 2, measured pre-procedure
Primary	Change in oxygen saturation	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.	Measured during painful procedure
Primary	Change in oxygen saturation	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.	Measured immediately after painful procedure
Primary	Change in respiratory rate	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.	Baseline 1, measured pre-intervention
Primary	Change in respiratory rate	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.	Baseline 2, measured pre-procedure
Primary	Change in respiratory rate	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.	Measured during procedure
Primary	Change in respiratory rate	Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.	Measured immediately after procedure
Secondary	Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values.	3 minutes after painful procedure
Secondary	Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values.	5 minutes after painful procedure
Secondary	Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values.	10 minutes after painful procedure
Secondary	Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values.	3 minutes after painful procedure
Secondary	Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values.	5 minutes after painful procedure
Secondary	Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values.	10 minutes after painful procedure
Secondary	Recovery as measured by changes in somatosensory cortex activation	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values.	3 minutes after painful procedure
Secondary	Recovery as measured by changes in somatosensory cortex activation	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values.	5 minutes after painful procedure
Secondary	Recovery as measured by changes in somatosensory cortex activation	Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values	10 minutes after painful procedure
Secondary	Recovery as measured by changes in heart rate (HR)	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.	3 minutes after painful procedure
Secondary	Recovery as measured by changes in heart rate (HR)	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.	5 minutes after painful procedure
Secondary	Recovery as measured by changes in heart rate (HR)	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.	10 minutes after painful procedure
Secondary	Recovery as measured by changes in oxygen saturation	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor.	3 minutes after painful procedure
Secondary	Recovery as measured by changes in oxygen saturation	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor.	5 minutes after painful procedure
Secondary	Recovery as measured by changes in oxygen saturation	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor.	10 minutes after painful procedure
Secondary	Recovery as measured by changes in respiratory rate	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.	3 minutes after painful procedure
Secondary	Recovery as measured by changes in respiratory rate	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.	5 minutes after painful procedure
Secondary	Recovery as measured by changes in respiratory rate	The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.	10 minutes after painful procedure