Oral Glucose in Pain Alleviation Among Term Neonates

NCT ID: NCT03190980

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

5% glucose

neonates will receive 2 ml of 5% glucose before heel prick

Group Type: EXPERIMENTAL

5% glucose

Intervention Type: OTHER

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

30% glucose

neonates will receive 2 ml of 30% glucose before heel prick

Group Type: EXPERIMENTAL

30% glucose

Intervention Type: OTHER

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

Placebo

neonates will receive 2 ml of sterile water before heel prick

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

5% glucose

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

Intervention Type: OTHER

30% glucose

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amal Naous

Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Makassed General Hospital

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

1722017

Identifier Type: -

Identifier Source: org_study_id