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

Sponsor

Coombe Women and Infants University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00921544

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy of Prematurity	Other: Sucrose Other: Sterile water	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Sweeties
Placebo Comparator: Sterile water 0.2 mls of sterile water	Other: Sterile water Sterile water administered 2 mins prior to eye exam

Arm

Intervention/Treatment

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 Names:

Sweeties

Placebo Comparator: Sterile water

0.2 mls of sterile water

Other: Sterile water

Sterile water administered 2 mins prior to eye exam

Outcome Measures

Primary Outcome Measures

Pain profile score as assessed by NPASS [Scores assessed 3 months following completion of study]

Secondary Outcome Measures

Number of adverse events [Assessed 3 months following completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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