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Methods of pain relief during the Eye Examination and their neurobehavioral effects in prematuros: randomized clinical test

Neurobehavioral and physiological responses of pain in preterm infants: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8949x2
Enrollment
Unknown
Registered
2019-04-22
Start date
2017-10-24
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

Stably preterm hemodynamically hospitalized in the Neonatal Intensive Care Unit (NICU), submitted to fundus examination for the screening of retinopathy of prematurity. Keywords: Premature

Interventions

The sample will be composed of 33 premature infants who will be randomized into 3 groups (each group with 11 preterm infants), 1 control group (facilitated containment) and 2 intervention groups (brea
2. During the examination in the right eye
3. 30-second interval between one eye and another
4. During the examination in the left eye
5. In the first five minutes after the end of the examination
6. From the sixth to the tenth minute after the end of the exam.
Drug
Behavioural
Dietary supplement
Other

Sponsors

Faculdade de Ceilândia da Universidade de Brasília
Lead Sponsor
Hospital Materno Infantil de Brasília (HMIB)
Collaborator

Eligibility

Age
30 Weeks to 37 Weeks

Inclusion criteria

Inclusion criteria: Preterm newborns, born with up to 32 weeks of gestational age and 1500g of weight; of both genders; with first eye examination scheduled after 30 days of life; which show hemodynamic stability, with parameters of heart rate and oxygen saturation within the normal range, up to 120 beats per minute or above 95% oxygen saturation respectively.

Exclusion criteria

Exclusion criteria: Premature infants who are in assisted ventilation will be excluded from the study; have grade III or IV intraventricular hemorrhage or subsequent leukomalacia; congenital nervous system disease, neurological and renal malformation or impairment, or use of opioids and corticosteroids among other drugs that interfere with nociceptive responses.

Design outcomes

Primary

MeasureTime frame
Changes in heart rate values in beats per minute (bpm). Checked or checked prior to eye fundus examination during the right eye examination for a period of 30 seconds during examination of the left eye within the first five minutes after examination from the sixth to the tenth minute after examination. Statistical analyzes of intra-group and inter-group values will be performed later.;Changes in oxygen saturation values (%). Checked or checked prior to eye fundus examination during the right eye examination for a period of 30 seconds during examination of the left eye within the first five minutes after examination from the sixth to the tenth minute after examination. Statistical analyzes of intra-group and inter-group values will be performed later.;Changes in crying time and alteration of facial mime. Measured or verified by analysis of the footage before the examination of the fundus of the eye during the examination in the right eye for a period of 30 seconds during examination of the left eye in the first five minutes after the examination from the sixth to the tenth minute after exam. Statistical analyzes of intra-group and inter-group values will be performed later.

Secondary

MeasureTime frame
Clinical influence of the interventions on the level of pain during the examination of the fundus of the eye through the statistical analysis of mean values of heart rate, oxygen saturation, crying time and alteration of the facial mimetic. Making intra-group comparisons and between intervention groups.

Countries

Brazil

Contacts

Public ContactAline;Anna Karolyne Toledo;Fernandes

Faculdade de Ceilândia da Universidade de Brasília;Fundação Hemocentro de Brasília

alinemartoledo@gmail.com;karolyne_cfernandes@yahoo.com.br+55-61-31078418/ +55-61-31078419/ +55-61-33770615;+55-61-34911881

Outcome results

None listed

Source: REBEC (via WHO ICTRP)