Analgesic Effect of Oral Glucose in Neonates

Efficacy of Oral Glucose in Pain Alleviation Among Healthy Term Neonates Undergoing Circumcision

Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.

OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.

STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.

POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.

OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.

Secondary outcome is to assess effect of 30% glucose oh physiologic parameters

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • Makassed General Hospital
    • Contact: Amal Naous, MD; Phone Number: 6941 +9611636000; Email: amalnaous@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Estimated gestational age: 37 weeks-42 weeks
• Birth weight: 2500 grams-4000 grams
• Apgar scores a minimum of 7 at 1 and 5 minutes respectively
• Heart rate between 100 and 160 per minutes
• Blood O2 saturation of at least 95%
• No recognized congenital abnormalities

Exclusion Criteria:

• They were transferred to the neonatal intensive care unit (NICU)
• They required respiratory support

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose group; Neonates will receive 30% oral glucose	Other: 30% glucose; Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
Placebo Comparator: Placebo group; Neonates will receive sterile water	Other: Placebo; Male neonates will receive 2 ml of sterile water two minutes prior to circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.	Pain will be assessed 1 minute before the procedure and during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate (beats per minute) will be recorded	2 minutes before the procedure, during the procedure and one minute after the procedure
Respiratory rate	Respiratory rate (breaths per minute) will be recorded	2 minutes before the procedure, during the procedure and one minute after the procedure
Oxygen saturation	Oxygen saturation (in percent) will be recorded	2 minutes before the procedure, during the procedure and one minute after the procedure

Collaborators and Investigators

• Sponsor: Makassed General Hospital
• Investigators: Principal Investigator: Amal Naous, MD, Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18122019

Drug and device information, study documents

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