Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635174
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Efficacy of 50 Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of 50 Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine the effect of 50 oral dextrose in reducing pain before Bladder Catheterization
This study will answer the following question
Is there any effect of 50 dextrose in reducing pain response to infants from age 1-90 days undergoing bladder catheterization during their visit in emergency department it is double blind randomized control trial comparing 2ml 50 dextrose as oral solution with placebo 2ml of normal water
Primary Objective
- To evaluate the impact of administrating oral glucose on pain control compared with placebo in blood pressure Heart rate respiratory rate and oxygen saturation before and after the procedure
Secondary Objectives
To compare random blood sugar before and after the procedure
To compare the incident and the duration of crying in both groups
administration of oral solution 2ml of solutions to be administered orally as drops at tip of the tongue after that will wait for 2 minutes before the procedure start after 2 minutes from the oral solution the procedure will start
This study will answer the following question
Is there any effect of 50 dextrose in reducing pain response to infants from age 1-90 days undergoing bladder catheterization during their visit in emergency department it is double blind randomized control trial comparing 2ml 50 dextrose as oral solution with placebo 2ml of normal water
Primary Objective
- To evaluate the impact of administrating oral glucose on pain control compared with placebo in blood pressure Heart rate respiratory rate and oxygen saturation before and after the procedure
Secondary Objectives
To compare random blood sugar before and after the procedure
To compare the incident and the duration of crying in both groups
administration of oral solution 2ml of solutions to be administered orally as drops at tip of the tongue after that will wait for 2 minutes before the procedure start after 2 minutes from the oral solution the procedure will start
Detailed Description:
During first days of the life of New-borns they go through a lot of painful procedures such as blood tests and immunizations that lead to painful experiences and distress For long period of time it was believed that young children do not feel the painful stimuli Recent studies have proven that they have all the anatomical physiological and neurochemical system to feel for the pain 1 In fact they have low threshold for the pain stimuli due to immature suppressive mechanism 2 There are several consequences that pain can cause to children such as respiratory distress changes in the metabolic and intracranial system induce significant behavioural reactions and increase sensitivity to pain
For these reasons as well as for ethical reasons it is advisable to find an acceptable method to reduce pain and distress during painful procedures Pharmacologic treatment is not recommended for New-borns with acute recurring and short-term painful procedures Studies has reported an alternative way which can be used for pain relive such as using oral sweeteners 3 World-widely national and international guidelines recommended the use of oral sweeteners such as Sucrose and glucose before painful procedures 4 Researchers found that administration of oral dextrose can raise the pain threshold by activating endogenous opioids 5 The maximum effect can be observed at 2 minutes after administration 6 It is not clear what is the exact effective dose that can be used during painful procedure 7 Several studies used 2ml of dextrose but other studies have reported an effect with 005 mL 8
Study done by thyr et al 9 shows sweet solution can be used as a simple and safe method to reduce the distress following immunization in infants up to 12 months A systematic review by Harrison et al 10 reported that Infants aged 1-12 months received oral sucrose or glucose before immunization had moderately reduced incidence and duration of crying
For these reasons as well as for ethical reasons it is advisable to find an acceptable method to reduce pain and distress during painful procedures Pharmacologic treatment is not recommended for New-borns with acute recurring and short-term painful procedures Studies has reported an alternative way which can be used for pain relive such as using oral sweeteners 3 World-widely national and international guidelines recommended the use of oral sweeteners such as Sucrose and glucose before painful procedures 4 Researchers found that administration of oral dextrose can raise the pain threshold by activating endogenous opioids 5 The maximum effect can be observed at 2 minutes after administration 6 It is not clear what is the exact effective dose that can be used during painful procedure 7 Several studies used 2ml of dextrose but other studies have reported an effect with 005 mL 8
Study done by thyr et al 9 shows sweet solution can be used as a simple and safe method to reduce the distress following immunization in infants up to 12 months A systematic review by Harrison et al 10 reported that Infants aged 1-12 months received oral sucrose or glucose before immunization had moderately reduced incidence and duration of crying
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None