Oral Glucose in Pain Alleviation Among Term Neonates

NCT03190980 | Completed

• 1 other identifier: 1722017
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

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

  2 minutes during the procedure

Secondary Outcomes (1)

• Occurance of adverse events

  5 minutes after the procedure

Study Arms (3)

5% glucose

EXPERIMENTAL

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

Other: 5% glucose

30% glucose

EXPERIMENTAL

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

Other: 30% glucose

Placebo

PLACEBO COMPARATOR

neonates will receive 2 ml of sterile water before heel prick

Other: Placebo

Interventions

5% glucose OTHER

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

5% glucose

30% glucose OTHER

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

30% glucose

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Conditions

Pain

Interventions

Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

LE (1)