- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467177
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amal Naous, MD
- Phone Number: 6317 +9611636000
- Email: amalnaous@hotmail.com
Study Locations
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucose group
Neonates will receive 30% oral glucose
|
Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
|
Placebo Comparator: Placebo group
Neonates will receive sterile water
|
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
Time Frame: 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.
|
Pain will be assessed 1 minute before the procedure and during the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
|
Heart rate (beats per minute) will be recorded
|
2 minutes before the procedure, during the procedure and one minute after the procedure
|
Respiratory rate
Time Frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
|
Respiratory rate (breaths per minute) will be recorded
|
2 minutes before the procedure, during the procedure and one minute after the procedure
|
Oxygen saturation
Time Frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
|
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
Investigators
- Principal Investigator: Amal Naous, MD, Makassed General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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