Analgesic Effect of Oral Glucose in Neonates

Not Applicable

• Conditions: Pain
• Interventions: Other: 30% glucose; Other: Placebo

• Registration Number: NCT04467177
• Lead Sponsor: Makassed General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-01
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-09
• Last Update Submitted: 2020-07-09
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose group	30% glucose	Neonates will receive 30% oral glucose
Placebo group	Placebo	Neonates will receive sterile water

Primary Outcome Measures

Name	Time	Method
Pain score	Pain will be assessed 1 minute before the procedure and during the procedure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon