Oral Glucose in Pain Alleviation Among Term Neonates

Study Overview
=================
Brief Summary
-----------------
Background: It was long believed that newborns could not experience pain. As it is now documented that newborns have all the necessary systems to perceive pain, pain management can no longer be ignored. Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and still there is debate regarding the efficacy of oral glucose, in different strengths, on alleviation of pain among neonates. Aim: The objective of this study is to assess the efficacy and safety oral administration of glucose, in different concentrations, on pain relief in full term neonates undergoing heel prick test. Methods: The investigators will conduct a prospective, randomized, double blind placebo controlled trial to investigate the effect of glucose solution on alleviating the pain of heel prick test in 244 healthy full term newborns who will be randomly allocated to one of three groups: First group will receive 5% glucose, second group will receive 30% glucose and third group will receive sterile water as a placebo, 2 minutes prior to the procedure. Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in heart rate, respiratory rate and oxygen saturation.

Detailed Description
-----------------
The investigators will conduct a prospective, randomized, double blind, placebo controlled study of healthy full term newborns delivered by normal vaginal delivery, undergoing heel prick test. They will be randomized to receive either 5% glucose, 30% glucose or sterile water as a placebo, 2 minutes prior to the procedure. The investigators will study the efficacy and safety of oral glucose, in different strengths, compared to placebo (sterile water) in pain alleviation. All parents will receive an explanation of the study before participation, and informed written consent will be signed by the parents for voluntary participation

Official Title
-----------------
Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: 5% glucose
* Other: 30% glucose
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated gestational age: 37 weeks-42 weeks Birth weight: 2500 grams- 4000 grams Mode of delivery: normal vaginal delivery Age: birth to 72 hours of life Apgar scores of at least 7 at 1 and 5 minutes Heart rate between 100 and 160 per minutes Blood O2 saturation ≥ 95% No known congenital anomalies Exclusion Criteria: They have history of birth trauma They are admitted to neonatal intensive care unit (NICU) They need respiratory support Their mothers are receiving sedatives or opioids during vaginal delivery

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% glucose<br>neonates will receive 2 ml of 5% glucose before heel prick | Other: 5% glucose<br>* Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed<br>|
| Experimental: 30% glucose<br>neonates will receive 2 ml of 30% glucose before heel prick | Other: 30% glucose<br>* Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed<br>|
| Placebo Comparator: Placebo<br>neonates will receive 2 ml of sterile water before heel prick | Other: Placebo<br>* Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS | 2 minutes during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurance of adverse events | local bruising or haematoma or hyperglycemia | 5 minutes after the procedure |