Oral Glucose in Pain Alleviation Among Term Neonates

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190980
• Other study ID #: 1722017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2020
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• 5% glucose
Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed
• 30% glucose
Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed
• Placebo
Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS	2 minutes during the procedure
Secondary	Occurance of adverse events	local bruising or haematoma or hyperglycemia	5 minutes after the procedure