Analgesic Effect of Oral 25% Glucose Versus Oral 24% Sucrose for Pain Relief During Heel Lance in Preterm Neonates
Condition: Pain
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      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)
    

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.
    

Intervention name(s): Sucrose; Glucose
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): 24% Sucrose; 25% Glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Preterm; Neonates; 24% Sucrose; 25% Dextrose