Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Procedural pain in neonates is recently acknowledged entity and many studies on the use of pharmacological as well as non pharmacological interventions for alleviation of this pain have been done. Of these, sucrose with or without non nutritive sucking has been the most widely studied and accepted form of pain relief. Its analgesic effect is thought to be mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).

Although, guidelines based on systematic reviews and meta-analysis for pain management recommend the use of sucrose solutions for pain relief during procedures, the use of repeated doses of sucrose with preterm neonates requires further investigation.

Pain may have profound consequences for preterm neonates during a critical time of brain development. Data derived from animal models suggests that repeated painful stimuli may result in structural and functional reorganization of the nervous system and alteration in future pain response. Early pain experience during this critical period in development are thought to have immediate and long term consequences that could influence physiological, behavioral and developmental outcomes. Early repetitive procedural pain related stress in very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1 This study aims to assess the effect of repeated painful stimuli on short term neurobehaviour of preterm infants and the efficacy of repeated doses of sucrose used for pain relief.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lady Hardinge Medical College
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. All preterms (more than equal to 32 weeks to less than 37 weeks)

2. within first 48 hrs of post natal life

3. Clinically stable from respiratory and hemodynamic point of view

4. Parental consent

Exclusion Criteria:

1. neonates requiring ventilatory support

2. neonates with any neurological impairment(HIE ,seizures)

3. receiving opiates or born to mothers receiving opiates

4. newborns who have received muscle relaxants ,sedatives or analgesics

5. grade 3 or 4 IVH

6. major congenital anomalies

7. 5 mins apgar of less than 7

8. Neonates undergoing any surgery

9. Birth trauma