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Effect of skin-to-skin compared to the sweet solution for pain relief in newborns who require repeated blood collection.

Effect of skin-to-skin compared to sucrose for pain relief in infants undergoing repeated painful procedures: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7nynr7
Enrollment
Unknown
Registered
2014-05-28
Start date
2013-06-06
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Pain in newborn related to repeated heel puncture.

Interventions

The therapeutic intervention will be evaluated to skin contact ( experimental group - GE ) and control is 25 % sucrose . During the procedure , the newborns ( NB) GE will be positioned in dorsal posit
Procedure/surgery
Behavioural

Sponsors

Escola de Enfermagem de Ribeirão Preto-USP
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto-Universidade de São Paulo
Collaborator

Eligibility

Age
4 Hours to 12 Hours

Inclusion criteria

Inclusion criteria: Inclusion criteria: infants with gestational age greater than or equal to 36 weeks, which present Apgar score> 7 at 5 minutes and clinical stability with maintaining physiological parameters in the normal range, ie, heart rate between 120 to 160 beats per minute (bpm). Mothers whose children are randomly assigned as skin to skin contact should be in physical and emotional conditions to breastfeed.

Exclusion criteria

Exclusion criteria: Exclusion criteria: infants who had birth trauma (fractures, skin lesions, soft tissue injuries cortocontusos, adiponecrose, bleeding from the sternocleidomastoid, brachial palsy, facial paresis, trauma of the sternocleidomastoid, intracranial hemorrhage, visceral rupture, bilateral paralysis of vocal cords, brachial palsy, facial palsy, spinal trauma and spinal cord and diaphragm paralysis), congenital malformations, difficulty swallowing, use of opioids in preterm and/or the mother less than six hours, presence of severe intraventricular hemorrhage or subsequent periventricular and contraindications of breastfeeding .

Design outcomes

Primary

MeasureTime frame
The main outcome is reactivity of the newborn in relation to pain and which will be examined by changing the mime's facial RN according to NFCS (Neonatal Facial Coding System) adapted. Trained coders will code the images recorded with digital camera, within 20 seconds of each stage of data collection. Is expected that in the AM group the NFCS adapted, will be equal to the group sucrose.;The heart rate will be evaluated continuously (second by second) using the Polar RS 800, during all phases of data collection. The monitoring will be done by means of two electrodes (Red Dot for RN) glued to the chest, in the region of the nipples, of the newborn, and connected to the Polar RS 800. The data will be analyzed in relation to the minimum, maximum and average of each phase.

Secondary

MeasureTime frame
The state of sleeping and waking and crying are measured from the parameters described by Prechtl (1974): deep sleep, active sleep, quiet alert, active alert and crying. The evaluation of the images with respect to sleep and waking will be made by two trained coders, continuous (second-by-second) at all stages of data collection.

Countries

Brazil

Contacts

Public ContactLiciane Montanholi

Escola de Enfermagem de Ribeirão Preto- Universidade de São Paulo

licianelm@gmail.com+55 (16) 3602 3411

Outcome results

None listed

Source: REBEC (via WHO ICTRP)