Analgesic Effect of Oral 25% Glucose Versus Oral 24% Sucrose for Pain Relief During Heel Lance in Preterm Neonates

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Lady Hardinge Medical College
Sponsor:
Information provided by (Responsible Party):
DR. VIKRAM DATTA, Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01931020
First received: August 21, 2013
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

RESEARCH HYPOTHESIS-In preterm neonates during heel lance oral 25% glucose is more efficacious in reducing pain as compared to oral 24% sucrose when assessed by PIPP(Premature infant pain profile)


Condition Intervention
Pain
Drug: Sucrose
Drug: Glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Randomised Controlled Trial to Compare the Efficacy of Oral 25% Glucose With Oral 24% Sucrose for Pain Relief During Heel Lance in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Painful response [ Time Frame: 30 seconds after heel lance ] [ Designated as safety issue: No ]
    Premature Infant Pain Profile(PIPP)


Secondary Outcome Measures:
  • Duration of Crying [ Time Frame: Within 2 minutes following the procedure ] [ Designated as safety issue: No ]
    Duration of crying will be taken as the time between the first crying sound till total silence


Other Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Within 2 minutes following the procedure ] [ Designated as safety issue: No ]
    • Choking, coughing or vomiting
    • Sustained tachycardia (HR>200) for >15 seconds
    • Sustained bradycardia (HR<80) for >15 seconds
    • Sustained tachypnea (RR>80) for >15 seconds
    • Sustained dyspnea (RR<20) for >15 seconds
    • Sustained oxygen desaturation <80% for >15 seconds


Estimated Enrollment: 94
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sucrose
1ml of 24%sucrose will be administered prior to heel lance
Drug: Sucrose
The enrolled neonates will be administered 1ml of 24% sucrose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.
Other Name: 24% Sucrose
Experimental: Glucose
1ml of 25% glucose will be administered prior to heel lance
Drug: Glucose
The enrolled neonates will be administered 1ml of 25% gluose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.
Other Name: 25% Glucose

Detailed Description:

Pain is "an unpleasant sensory and emotional experience associated with actual or potential tissue damage". Evaluation of pain in neonates is difficult due to the subjective nature of pain and the inability of neonates to verbally express pain. Surrogate measures used to describe pain in neonates include motor responses, facial expressions, cry and changes in physiologic parameters like heart rate, blood pressure, oxygen saturation and respiratory rate. Various changes have been compiled to create various scores. Validated scores for the assessment of pain include Neonatal Facial Coding System, Neonatal Infant Pain Scale or Premature Infant Pain Profile. These reactions to pain may contribute to the development of hypoxia, hypercarbia, acidosis, ventilator asynchrony, pneumothoraces, reperfusion injury and venous congestion and subsequent late intraventricular hemorrhage (IVH) or late extension of early intraventricular hemorrhage and periventricular leukomalacia. These behavioral changes may also disrupt postnatal adaptation, parent-infant bonding and feeding schedules.

Newborn infants routinely undergo painful invasive procedures, even after uncomplicated birth. Evidence shows that neonates do feel pain and may even have increased sensitivity to pain and to its long term effects compared with older infants. Treating procedural pain has become a crucial part of neonatal care. In healthy infants, the most common painful procedures are heel lance and venipuncture. Though minimally invasive, lancing is a painful procedure that activates cortical areas in brain .Repetitive procedural pain can lead to changes in the pain sensitivity threshold therefore, adequate analgesic control is needed. Pharmacological treatments are rarely used during these procedures because of concerns about their effectiveness (topical local anesthetics or paracetamol for heel pricks) and potential adverse effects (central analgesics). Therefore, non-pharmacological interventions are valuable alternatives. Recent interventions such as sweet oral solutions (sucrose or glucose) and non-nutritive sucking have been used frequently to alleviate pain.

Use of sucrose in preterm neonates has been advocated uniformly for pain relief. However, recently few reports have raised concerns over its safety and effect on neurodevelopment. Glucose has been used in pain relief in neonates but its therapeutic efficacy in comparison to oral sucrose in direct adequately powered RCT with pain assessment tools has not been evaluated in the Indian subcontinent. The present study was planned to evaluate the efficacy of 25% glucose solution with 24% sucrose solution for analgesia during heel lance in preterm neonates.

LACUNAE IN EXISTING KNOWLEDGE Existing literature on efficacy of glucose vs. sucrose is inconclusive on superiority of either. When a Medline search was carried out it returned limited results and no results returned from the Indian subcontinent which compared the two solutions using a multidimensional pain assessment tool. There is a need for an efficacious and cheap substitute which is readily available in NICU settings and sterile. Hence, the role of 25% Glucose in neonatal pain relief and safety associated with its use needs to be evaluated.

  Eligibility

Ages Eligible for Study:   34 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants born at <37 weeks of gestational age
  • Infants within first 48 hours of post natal life
  • Infants having clinical indication for blood sampling
  • Parental consent

Exclusion Criteria:

  • Infants born with perinatal asphyxia, birth trauma, cardiorespiratory instability
  • Infants with 5min APGAR score <7
  • Infants having any syndromes, congenital anomalies or previous surgery
  • Infants born to mothers known to be receiving opiates
  • Infants administered muscle relaxants, sedatives & analgesics
  • Infants born under general anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931020

Contacts
Contact: Vikram Datta, MD 9350801230 drvikramdatta@gmail.com

Locations
India
Lady Hardinge Medical College Recruiting
New Delhi, Delhi1, India, 110001
Contact: Vikram Datta, MD    9350801230    drvikramdatta@gmail.com   
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Principal Investigator: Vikram Datta, MD Lady Hardinge Medical College, New Delhi
  More Information

No publications provided

Responsible Party: DR. VIKRAM DATTA, Principal Investigator, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01931020     History of Changes
Other Study ID Numbers: Glucose versus sucrose in pain
Study First Received: August 21, 2013
Last Updated: August 26, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Lady Hardinge Medical College:
Pain
Preterm
Neonates
24% Sucrose
25% Dextrose

ClinicalTrials.gov processed this record on October 01, 2014