Ali Al Qubtan
Muscat, Muḩāfaz̧at Masqaţ, 100, Oman
NCT Number: NCT06635174
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
Interested in participating?
Request Info1 day–90 day
All sexes
Interventional
Not applicable
Muscat, Muḩāfaz̧at Masqaţ, 100, Oman
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 0.05 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
we are using 2ml of 50% dextrose
patient will receive 2ml of normal water
Time frame: 3 minutes, 5 minutes and 7 minutes after oral solution will be administrated
blood pressure will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline.
for example (baseline blood pressure will be compared with the blood pressure during procedure after oral solution) the different of both blood pressure will be analyzed whiter there is significant change or not in both group
Time frame: 3 minutes, 5 minutes and 7 minutes after administration of oral solution
the Neonatal Infant Pain Scale (NIPS) will be calculated by trained treating nurse staff 3 minutes, 5 minutes and 7 minutes after administration of oral solution
Time frame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
heart rate will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline.
for example (baseline heart rate will be compared with the heart rate during procedure after oral solution) the different of both heart rate will be analyzed whiter there is significant change or not in both group
Time frame: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
respiratory rate will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline.
for example (baseline respiratory rate will be compared with the respiratory rate during procedure after oral solution) the different of both heart rate will be analyzed whiter there is significant change or not in both group
Time frame: 10 minutes
the random blood sugar of the patient will be compared before and after administration of oral solution
Time frame: 10 minutes
the duration of crying in placebo group will be calculated from time of starting procedure to the time in which child will stop crying
Time frame: 10 minutes
the duration of crying in dextrose group will be calculated from time of starting procedure to the time in which child will stop crying
Oman Medical Speciality Board
Other Gov
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