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PainNCT01931020

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

A study testing Sucrose and Glucose in people with Pain, run by Lady Hardinge Medical College at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 34 to 37 weeksHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Sucrose and Glucose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteIndia
Study dates
Jul 2013to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 34 to 37 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Lady Hardinge Medical College

    New Delhi, Delhi1, 110001

Other trials in India

About this study

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

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)

Read the 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.

Conditions
Pain
Being tested
Sucrose, Glucose
Keywords
Pain, Preterm, Neonates, 24% Sucrose, 25% Dextrose
Medical subject headings
Pain, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SucroseDrug

    Also called 24% 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.

  • GlucoseDrug

    Also called 25% 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.

Study groups in NCT01931020
Study groupRoleWhat they receive
SucroseActive comparator1ml of 24%sucrose will be administered prior to heel lance
Receives: Drug: Sucrose
GlucoseExperimental1ml of 25% glucose will be administered prior to heel lance
Receives: Drug: Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Painful response

    Premature Infant Pain Profile(PIPP)

    Measured: 30 seconds after heel lance

Secondary outcomes (1)
  1. Duration of Crying

    Duration of crying will be taken as the time between the first crying sound till total silence

    Measured: Within 2 minutes following the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931020
Sponsor's protocol ID
Glucose versus sucrose in pain
Status last verified
Jun 2016
First submitted
21 Aug 2013
Last updated
27 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Sucrose and Glucose in people with Pain, run by Lady Hardinge Medical College at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Painful response (time frame: 30 seconds after heel lance). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.

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