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Completed

NCT Number: NCT03190980

Oral Glucose in Pain Alleviation Among Term Neonates

Background: It was long believed that newborns could not experience pain. As it is now documented that newborns have all the necessary systems to perceive pain, pain management can no longer be ignored.

Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and still there is debate regarding the efficacy of oral glucose, in different strengths, on alleviation of pain among neonates.

Aim: The objective of this study is to assess the efficacy and safety oral administration of glucose, in different concentrations, on pain relief in full term neonates undergoing heel prick test.

Methods: The investigators will conduct a prospective, randomized, double blind placebo controlled trial to investigate the effect of glucose solution on alleviating the pain of heel prick test in 244 healthy full term newborns who will be randomly allocated to one of three groups: First group will receive 5% glucose, second group will receive 30% glucose and third group will receive sterile water as a placebo, 2 minutes prior to the procedure.

Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in heart rate, respiratory rate and oxygen saturation.

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Key information

Conditions

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

Age range

24 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

The investigators will conduct a prospective, randomized, double blind, placebo controlled study of healthy full term newborns delivered by normal vaginal delivery, undergoing heel prick test. They will be randomized to receive either 5% glucose, 30% glucose or sterile water as a placebo, 2 minutes prior to the procedure. The investigators will study the efficacy and safety of oral glucose, in different strengths, compared to placebo (sterile water) in pain alleviation.

All parents will receive an explanation of the study before participation, and informed written consent will be signed by the parents for voluntary participation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Estimated gestational age: 37 weeks-42 weeks
  • Birth weight: 2500 grams- 4000 grams
  • Mode of delivery: normal vaginal delivery
  • Age: birth to 72 hours of life
  • Apgar scores of at least 7 at 1 and 5 minutes
  • Heart rate between 100 and 160 per minutes
  • Blood O2 saturation ≥ 95%
  • No known congenital anomalies

Exclusion criteria

  • They have history of birth trauma
  • They are admitted to neonatal intensive care unit (NICU)
  • They need respiratory support
  • Their mothers are receiving sedatives or opioids during vaginal delivery

Treatment and study plan

5% glucose

Other

Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed

30% glucose

Other

Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed

Placebo

Other

Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed

Primary outcomes

  1. Pain score

    Time frame: 2 minutes during the procedure

    Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS

Secondary outcomes

  1. Occurance of adverse events

    Time frame: 5 minutes after the procedure

    local bruising or haematoma or hyperglycemia

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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