PainNCT03486015
Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination
A study testing Sterile water and 30% glucose in people with Pain, run by Region Örebro County.
Trial summary
This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants. Read more about this study
- Who is it for?
- Ages 37 weeks and older
- Conditions the study is for
- Pain
- What is being tested?
- Sterile water and 30% glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 10 Apr 2017
- 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 37 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy, fullterm infants that were undergoing a routine medical examination
Who cannot join
- Prematurity
- Parents inability to speak Swedish well enough to give consent
- Congenital malformations or other illnesses
- Any pain-relieving medicine administered in the previous 24 hours
About this study
This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.
Read the detailed description
All healthy, fullterm infants undergoes a medical examination after birth where 21 different components are assessed. One of the components is the hip examination which appears to be painful. Since painful experiences early in life can cause longterm negative effects it is important to treat pain during painful procedures.
One hundred healthy, fullterm infants were randomized to either glucose or sterile water orally before the routine medical examination before discharge from the maternity ward.
- Conditions
- Pain
- Being tested
- Sterile water, 30% glucose
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile waterDrug
2 ml of sterile water
30% glucoseDrug
2 ml of 30% glucose
| Study group | Role | What they receive |
|---|---|---|
| 30% glucose | Experimental | This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant. Receives: Drug: 30% glucose |
| Sterile water | Placebo comparator | This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant. Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse
Pain assessment instrument
Measured: The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.
Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician
Pain assessment instrument
Measured: The physician will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent
Pain assessment instrument
Measured: The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Total crying time will be measured
Total amount of time (in minutes) the infant is crying during the examination.
Measured: The total crying time is measured throughout the examination from zero minutes until approximately 10 minutes after the study solution has been given with the help of a stopwatch.
Crying time during hip examination
The amount of time (in minutes) the infant is crying during the hip examination.
Measured: The total crying time is measured from approximately 3 minutes from the study solution has been given until the hip examination has been completed (approx. during 30 sec up to 1 min) with the help of a stopwatch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Mar 2016
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486015
- Sponsor's protocol ID
- 186081
- Status last verified
- Mar 2018
- First submitted
- 7 Feb 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination
- ClinicalTrials.gov ID
- NCT03486015
- Acronym / sponsor ID
- 186081
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 3 Apr 2018 (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.
This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.
Detailed description
All healthy, fullterm infants undergoes a medical examination after birth where 21 different components are assessed. One of the components is the hip examination which appears to be painful. Since painful experiences early in life can cause longterm negative effects it is important to treat pain during painful procedures.
One hundred healthy, fullterm infants were randomized to either glucose or sterile water orally before the routine medical examination before discharge from the maternity ward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30% glucose | Experimental | Drug: 30% glucoseThis group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant. |
| Sterile water | Placebo comparator | Drug: Sterile waterThis group will be given 2 ml of sterile water in the mouth before the physical examination of the infant. |
Who may qualify
- Ages
- 37 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, fullterm infants that were undergoing a routine medical examination
Key exclusion criteria (4 listed)
- Prematurity
- Parents inability to speak Swedish well enough to give consent
- Congenital malformations or other illnesses
- Any pain-relieving medicine administered in the previous 24 hours
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 |
|---|---|---|
| Sterile water2 ml of sterile water | Drug | Sterile water |
| 30% glucose2 ml of 30% glucose | Drug | 30% glucose |
Primary outcome
Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse
Time frame: The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.
Pain assessment instrument
Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician
Time frame: The physician will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Pain assessment instrument
Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent
Time frame: The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Pain assessment instrument
Total crying time will be measured
Time frame: The total crying time is measured throughout the examination from zero minutes until approximately 10 minutes after the study solution has been given with the help of a stopwatch.
Total amount of time (in minutes) the infant is crying during the examination.
Crying time during hip examination
Time frame: The total crying time is measured from approximately 3 minutes from the study solution has been given until the hip examination has been completed (approx. during 30 sec up to 1 min) with the help of a stopwatch
The amount of time (in minutes) the infant is crying during the hip examination.
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 3 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile water and 30% glucose in people with Pain, run by Region Örebro County.
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 1 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse (time frame: The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.). The study lists 5 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 3 Apr 2018.