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

NCT01190995 | Completed Phase 3

• 1 other identifier: Pain and Neurobehaviour
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain

Keywords

Pain; Neonate; Procedure; Neurobehavioural outcome

Outcome Measures

Primary Outcomes (1)

• Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the NAPI scale.

  Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the(Neurobehavioural Assessment of Preterm Infant) NAPI scale.

  40 weeks of post conceptional age.

Study Arms (2)

Sucrose

EXPERIMENTAL

The enrolled neonates will be administered a sterile solution of 24 % sucrose orally for a period of 7 days from enrollment The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure.

Drug: 24% Sucrose; Drug: Placebo

Placebo

PLACEBO COMPARATOR

The enrolled neonates will be administered double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure

Drug: Placebo

Interventions

24% Sucrose DRUG

The enrolled neonates will be administered either a sterile solution of 24 % sucrose or double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure

Also known as: Sucrose

Sucrose

Placebo DRUG

The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure

Also known as: Distilled Water

Placebo; Sucrose

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All preterms (more than equal to 32 weeks to less than 37 weeks)
• within first 48 hrs of post natal life
• Clinically stable from respiratory and hemodynamic point of view
• Parental consent

You may not qualify if:

• neonates requiring ventilatory support
• neonates with any neurological impairment(HIE ,seizures)
• receiving opiates or born to mothers receiving opiates
• newborns who have received muscle relaxants ,sedatives or analgesics
• grade 3 or 4 IVH
• major congenital anomalies
• mins apgar of less than 7
• Neonates undergoing any surgery
• Birth trauma

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (2)

Lady Hardinge Medical College

New Delhi, New Delhi, 110001, India

Location

Lady Hardinge Medical College,New Delhi

Delhi, India

Location

MeSH Terms

Conditions

Pain

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• VIKRAM DATTA, MD

  Lady Hardinge Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

IN (2)