Analgesic Effect of Oral Glucose in Neonates

NCT ID: NCT04467177

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-06-30

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

Conditions

Pain

Study Design

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

Study Groups

Glucose group

Neonates will receive 30% oral glucose

Group Type: EXPERIMENTAL

30% glucose

Intervention Type: OTHER

Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision

Placebo group

Neonates will receive sterile water

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Male neonates will receive 2 ml of sterile water two minutes prior to circumcision

Interventions

30% glucose

Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision

Intervention Type: OTHER

Placebo

Male neonates will receive 2 ml of sterile water two minutes prior to circumcision

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amal Naous

Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Naous, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

Makassed General Hospital

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Amal Naous, MD

Role: CONTACT

amalnaous@hotmail.com

+9611636000 ext. 6317

Facility Contacts

Amal Naous, MD

Role: primary

amalnaous@hotmail.com

+9611636000 ext. 6941

Other Identifiers

18122019

Identifier Type: -

Identifier Source: org_study_id