PainNCT03190980
Oral Glucose in Pain Alleviation Among Term Neonates
A study testing 5% glucose and 30% glucose in people with Pain, run by Makassed General Hospital at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 72 hours
- Conditions the study is for
- Pain
- What is being tested?
- 5% glucose and 30% glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteLebanon
- Study dates
- 1 May 2017to 30 Jun 2018
- 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 24 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates
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.
Read more
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.
Read the 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
- Conditions
- Pain
- Being tested
- 5% glucose, 30% glucose, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% glucoseOther
Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed
30% glucoseOther
Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed
PlaceboOther
Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed
| Study group | Role | What they receive |
|---|---|---|
| 5% glucose | Experimental | neonates will receive 2 ml of 5% glucose before heel prick Receives: Other: 5% glucose |
| 30% glucose | Experimental | neonates will receive 2 ml of 30% glucose before heel prick Receives: Other: 30% glucose |
| Placebo | Placebo comparator | neonates will receive 2 ml of sterile water before heel prick Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS
Measured: 2 minutes during the procedure
Secondary outcomes (1)
Occurance of adverse events
local bruising or haematoma or hyperglycemia
Measured: 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 May 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Naous, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190980
- Sponsor's protocol ID
- 1722017
- Status last verified
- Apr 2020
- First submitted
- 13 Jun 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates
- ClinicalTrials.gov ID
- NCT03190980
- Acronym / sponsor ID
- 1722017
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Jun 2017 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5% glucose | Experimental | Other: 5% glucoseneonates will receive 2 ml of 5% glucose before heel prick |
| 30% glucose | Experimental | Other: 30% glucoseneonates will receive 2 ml of 30% glucose before heel prick |
| Placebo | Placebo comparator | Other: Placeboneonates will receive 2 ml of sterile water before heel prick |
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 5% glucoseNeonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed | Other | 5% glucose |
| 30% glucoseNeonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed | Other | 30% glucose |
| PlaceboNeonates will receive sterile water, then heel prick wil be performed during which pain will be assessed | Other | Placebo |
Primary outcome
Pain score
Time frame: 2 minutes during the procedure
Pain responses will be evaluated using the Neonatal Infant Pain Scale NIPS
1 secondary outcome
Occurance of adverse events
Time frame: 5 minutes after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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 5% glucose and 30% glucose in people with Pain, run by Makassed General Hospital at 1 site in Lebanon.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score (time frame: 2 minutes during the procedure). 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 7 Apr 2020.