Oral Glucose in Pain Alleviation Among Term Neonates

Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: 5% glucose; Other: 30% glucose; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Makassed General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5% glucose; neonates will receive 2 ml of 5% glucose before heel prick	Other: 5% glucose; Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed
Experimental: 30% glucose; neonates will receive 2 ml of 30% glucose before heel prick	Other: 30% glucose; Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed
Placebo Comparator: Placebo; neonates will receive 2 ml of sterile water before heel prick	Other: Placebo; Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS	2 minutes during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurance of adverse events	local bruising or haematoma or hyperglycemia	5 minutes after the procedure

Collaborators and Investigators

• Sponsor: Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1722017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No