Neonatal Pain, Pain Management
Conditions
Keywords
50% dextrose, neonatal pain management
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
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 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.
Interventions
OTHERDextrose
we are using 2ml of 50% dextrose
OTHERnormal water
patient will receive 2ml of normal water
Sponsors
Oman Medical Speciality Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomization will be generated at the local pharmacy by a computer program in blocks of two and the randomization allotment only will be known by a pharmacist not involved in the care of the children. after that the pharmacist will prepper the syringe than contain the 2ml 50% dextrose or the placebo 2ml normal water. each syringe will have code. the code key will be only with the pharmacist.
Intervention model description
Total of 90 patient divided randomly in 2 groups, one group will receive 2ml of 50% oral dextrose and control group will receive 2ml of normal water as placebo. The Neonatal Infant Pain Scale (NIPS) will be used to measure the pain score among the infants. It was designed and validated in Canada by Lawrence J Alcock D et al. It uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) Parameters Facial expression Cry Breathing patterns Arms Legs State of arousal
Eligibility
Sex/Gender
ALL
Age
1 Days to 90 Days
Healthy volunteers
No
Inclusion criteria
* Age from 1 day to 90 days * Did not received analgesia for last 6 hours
Exclusion criteria
* Preterm newborns presenting in ED younger than 38 weeks (corrected age) * Unstable child * Suspicion of enterocolitis * Esophageal- tracheal fistula not operated * Known case of fructose intolerance * Oral congenital malformation (cleft palate)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in blood pressure | 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 |
| change in The Neonatal Infant Pain Scale (NIPS) | 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 |
| change in the heart rate | 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 |
| change in respiratory rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the duration of crying in placebo group | 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 |
| the duration of crying in dextrose group | 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 |
| random blood sugar | 10 minutes | the random blood sugar of the patient will be compared before and after administration of oral solution |
Countries
Oman
Outcome results
None listed