NCT03190980

Oral Glucose in Pain Alleviation Among Term Neonates

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Makassed General Hospital · Academic / Other
• Sex: All
• Age: 24 Hours – 72 Hours
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	5% glucose	Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed
OTHER	30% glucose	Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed
OTHER	Placebo	Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-06-19
• Last updated: 2020-04-07

Locations

1 site across 1 country: Lebanon