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

C

Coombe Women and Infants University Hospital

Status and phase

Completed
Phase 4

Conditions

Retinopathy of Prematurity

Treatments

Other: Sucrose
Other: Sterile water

Study type

Interventional

Funder types

Other

Identifiers

NCT00921544
Coombesucrose

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Oral Sucrose
Active Comparator group
Description:
Oral sucrose administered 2 mins prior to eye exam
Treatment:
Other: Sucrose
Sterile water
Placebo Comparator group
Description:
0.2 mls of sterile water
Treatment:
Other: Sterile water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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