NCT04467177

Analgesic Effect of Oral Glucose in Neonates

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Makassed General Hospital · Academic / Other
• Sex: Male
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	30% glucose	Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
OTHER	Placebo	Male neonates will receive 2 ml of sterile water two minutes prior to circumcision

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-07-10
• Last updated: 2020-07-10

Locations

1 site across 1 country: Lebanon