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Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening

Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00921544
Enrollment
40
Registered
2009-06-16
Start date
2008-08-31
Completion date
2009-03-31
Last updated
2009-06-16

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

Conditions

Retinopathy of Prematurity

Keywords

ROP, sucrose, pain

Brief summary

Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae. Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated. The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening. Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.

Interventions

OTHERSucrose

0.2 ml sucrose 24% given by mouth using a syringe and pacifier

OTHERSterile water

Sterile water administered 2 mins prior to eye exam

Sponsors

Coombe Women and Infants University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* \< 1500 grams * \< 32 weeks

Exclusion criteria

* Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation * Infants where consent to participate was not obtained

Design outcomes

Primary

MeasureTime frame
Pain profile score as assessed by NPASSScores assessed 3 months following completion of study

Secondary

MeasureTime frame
Number of adverse eventsAssessed 3 months following completion

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026