PainNCT04467177
Analgesic Effect of Oral Glucose in Neonates
A study testing 30% glucose in people with Pain, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. Read more about this study
- Who is it for?
- Ages 1 day to 28 days, men only
- Conditions the study is for
- Pain
- What is being tested?
- 30% glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2020to Jun 2021
- 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 28 days
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age: 37 weeks-42 weeks
- Birth weight: 2500 grams-4000 grams
- Apgar scores a minimum of 7 at 1 and 5 minutes respectively
- Heart rate between 100 and 160 per minutes
- Blood O2 saturation of at least 95%
- No recognized congenital abnormalities
Who cannot join
- They were transferred to the neonatal intensive care unit (NICU)
- They required respiratory support
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Amal Naous, MD, +9611636000 ext. 6941, amalnaous@hotmail.com
About this study
Official title: Efficacy of Oral Glucose in Pain Alleviation Among Healthy Term Neonates Undergoing Circumcision
Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.
OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.
Read more
STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.
POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.
OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.
Secondary outcome is to assess effect of 30% glucose oh physiologic parameters
- Conditions
- Pain
- Being tested
- 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.
30% glucoseOther
Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
PlaceboOther
Male neonates will receive 2 ml of sterile water two minutes prior to circumcision
| Study group | Role | What they receive |
|---|---|---|
| Glucose group | Experimental | Neonates will receive 30% oral glucose Receives: Other: 30% glucose |
| Placebo group | Placebo comparator | Neonates will receive sterile water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.
Measured: Pain will be assessed 1 minute before the procedure and during the procedure
Secondary outcomes (3)
Heart rate
Heart rate (beats per minute) will be recorded
Measured: 2 minutes before the procedure, during the procedure and one minute after the procedure
Respiratory rate
Respiratory rate (breaths per minute) will be recorded
Measured: 2 minutes before the procedure, during the procedure and one minute after the procedure
Oxygen saturation
Oxygen saturation (in percent) will be recorded
Measured: 2 minutes before the procedure, during the procedure and one minute 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 posted10 Jul 2020
- Study start1 Jul 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Naous, Makassed General Hospital
- Investigators
- Amal Naous, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467177
- Sponsor's protocol ID
- 18122019
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 10 Jul 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Glucose in Pain Alleviation Among Healthy Term Neonates Undergoing Circumcision
- ClinicalTrials.gov ID
- NCT04467177
- Acronym / sponsor ID
- 18122019
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Jul 2020 (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: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.
OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.
STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.
POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.
OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.
Secondary outcome is to assess effect of 30% glucose oh physiologic parameters
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose group | Experimental | Other: 30% glucoseNeonates will receive 30% oral glucose |
| Placebo group | Placebo comparator | Other: PlaceboNeonates will receive sterile water |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Estimated gestational age: 37 weeks-42 weeks
- Birth weight: 2500 grams-4000 grams
- Apgar scores a minimum of 7 at 1 and 5 minutes respectively
- Heart rate between 100 and 160 per minutes
- Blood O2 saturation of at least 95%
Key exclusion criteria (2 listed)
- They were transferred to the neonatal intensive care unit (NICU)
- They required respiratory support
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 |
|---|---|---|
| 30% glucoseMale neonates will receive 2 ml of 30% glucose two minutes prior to circumcision | Other | Glucose group |
| PlaceboMale neonates will receive 2 ml of sterile water two minutes prior to circumcision | Other | Placebo group |
Primary outcome
Pain score
Time frame: Pain will be assessed 1 minute before the procedure and during the procedure
Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.
3 secondary outcomes
Heart rate
Time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
Respiratory rate
Time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
Oxygen saturation
Time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
Amal Naous, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 6 inclusion and 2 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 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal Naous, MD (+9611636000 ext. 6317, amalnaous@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Pain will be assessed 1 minute before the procedure and 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 10 Jul 2020.