Analgesic Effect of Oral Glucose in Neonates

Study Overview
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Brief Summary
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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

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

Conditions
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Pain

Intervention / Treatment
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* Other: 30% glucose
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose group<br>Neonates will receive 30% oral glucose | Other: 30% glucose<br>* Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision<br>|
| Placebo Comparator: Placebo group<br>Neonates will receive sterile water | Other: Placebo<br>* Male neonates will receive 2 ml of sterile water two minutes prior to circumcision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate (beats per minute) will be recorded | 2 minutes before the procedure, during the procedure and one minute after the procedure | 
| Respiratory rate | Respiratory rate (breaths per minute) will be recorded | 2 minutes before the procedure, during the procedure and one minute after the procedure | 
| Oxygen saturation | Oxygen saturation (in percent) will be recorded | 2 minutes before the procedure, during the procedure and one minute after the procedure |