Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinopathy of Prematurity |
Other: Sucrose Other: Sterile water |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial |
- Pain profile score as assessed by NPASS [ Time Frame: Scores assessed 3 months following completion of study ] [ Designated as safety issue: No ]
- Number of adverse events [ Time Frame: Assessed 3 months following completion ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oral Sucrose
Oral sucrose administered 2 mins prior to eye exam
|
Other: Sucrose
0.2 ml sucrose 24% given by mouth using a syringe and pacifier
Other Name: Sweeties
|
|
Placebo Comparator: Sterile water
0.2 mls of sterile water
|
Other: Sterile water
Sterile water administered 2 mins prior to eye exam
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Ireland | |
| Coombe Women and Infants University Maternity Hospital | |
| Dublin, Ireland, 8 | |
| Study Director: | Eugene Dempsey, MD, FRCPI | Coombe Women and Infants University Hospital |
More Information
No publications provided
| Responsible Party: | Eugene Dempsey, Coombe Women and Infants University Hospital |
| ClinicalTrials.gov Identifier: | NCT00921544 History of Changes |
| Other Study ID Numbers: | Coombesucrose |
| Study First Received: | June 10, 2009 |
| Last Updated: | June 15, 2009 |
| Health Authority: | Ireland: Medical Ethics Research Committee |
Keywords provided by Coombe Women and Infants University Hospital:
|
ROP sucrose pain |
Additional relevant MeSH terms:
|
Retinal Diseases Retinopathy of Prematurity Eye Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 22, 2013