Pain ManagementNCT06635174
Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
A study testing Dextrose and normal water in people with Pain Management and Neonatal Pain, run by Oman Medical Speciality Board at 1 site in Oman.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Pain Management, Neonatal Pain
- What is being tested?
- Dextrose and normal water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteOman
- Study dates
- 9 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 1 day to 90 days
- Did not received analgesia for last 6 hours
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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
Read the 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.
- Conditions
- Pain Management, Neonatal Pain
- Being tested
- Dextrose, normal water
- Keywords
- 50% dextrose, neonatal pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroseOther
we are using 2ml of 50% dextrose
normal waterOther
patient will receive 2ml of normal water
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | in this arm participant will receive oral 2ml of normal water Receives: Other: normal water |
| 50% dextrose group | Experimental | this arm will include the participant who will receive 50% oral dextrose Receives: Other: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood pressure
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
Measured: 3 minutes, 5 minutes and 7 minutes after oral solution will be administrated
change in The Neonatal Infant Pain Scale (NIPS)
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
Measured: 3 minutes, 5 minutes and 7 minutes after administration of oral solution
change in the heart rate
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
Measured: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
change in respiratory rate
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
Measured: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
Secondary outcomes (3)
random blood sugar
the random blood sugar of the patient will be compared before and after administration of oral solution
Measured: 10 minutes
the duration of crying in placebo group
the duration of crying in placebo group will be calculated from time of starting procedure to the time in which child will stop crying
Measured: 10 minutes
the duration of crying in dextrose group
the duration of crying in dextrose group will be calculated from time of starting procedure to the time in which child will stop crying
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start9 Oct 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ali Redha Taqi Al Qubtan, Oman Medical Speciality Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635174
- Sponsor's protocol ID
- OmanMedAQ
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in randomized control trials. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
- ClinicalTrials.gov ID
- NCT06635174
- Acronym / sponsor ID
- OmanMedAQ
- Conditions
- Pain Management, Neonatal Pain
- Keywords
- 50% dextrose, neonatal pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: normal waterin this arm participant will receive oral 2ml of normal water |
| 50% dextrose group | Experimental | Other: Dextrosethis arm will include the participant who will receive 50% oral dextrose |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age from 1 day to 90 days
- Did not received analgesia for last 6 hours
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrosewe are using 2ml of 50% dextrose | Other | 50% dextrose group |
| normal waterpatient will receive 2ml of normal water | Other | control group |
Primary outcome
change in blood pressure
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
change in The Neonatal Infant Pain Scale (NIPS)
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
change in the heart rate
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
change in respiratory rate
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
3 secondary outcomes
random blood sugar
Time frame: 10 minutes
the duration of crying in placebo group
Time frame: 10 minutes
the duration of crying in dextrose group
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in randomized control trials. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose and normal water in people with Pain Management and Neonatal Pain, run by Oman Medical Speciality Board at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in blood pressure (time frame: 3 minutes, 5 minutes and 7 minutes after oral solution will be administrated). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.