Analgesic Effect of Oral Glucose in Neonates

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467177
• Other study ID #: 18122019
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: Makassed General Hospital
• Contact: Amal Naous, MD
• Phone: +9611636000
• Email: amalnaous[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• 30% glucose
Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
• Placebo
Male neonates will receive 2 ml of sterile water two minutes prior to circumcision

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	Heart rate (beats per minute) will be recorded	2 minutes before the procedure, during the procedure and one minute after the procedure
Secondary	Respiratory rate	Respiratory rate (breaths per minute) will be recorded	2 minutes before the procedure, during the procedure and one minute after the procedure
Secondary	Oxygen saturation	Oxygen saturation (in percent) will be recorded	2 minutes before the procedure, during the procedure and one minute after the procedure