PainNCT00150189
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
A study testing Sucrose in people with Pain and Procedural Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations. Read more about this study
- Who is it for?
- Ages 6 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural Pain
- What is being tested?
- Sucrose
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2003to 11 Oct 2006
- 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 6 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Currently between 2 and 4 months of age
- Birth between 37 and 42 weeks' completed gestation;
- Birth weight greater than 2.5 kg
- No evidence of acute or chronic disease processes.
Who cannot join
- They are experiencing concurrent illness
- They received an analgesic/sedative 6 hours prior to the office visit
- The infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization
- The infant has been introduced to solid food
- The infant may not receive a pacifier
- The infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered
- Language barriers preclude the process of obtaining parental consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Ambulatory Pediatric Clinic, Penn State Children's Hospital
Hershey, Pennsylvania, 17033
About this study
Official title: Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.
Read the detailed description
Acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. Immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. This study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. The proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn.
Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations
- Conditions
- Pain, Procedural Pain
- Being tested
- Sucrose
- Keywords
- Pain, Procedural Pain, Sucrose, Infant, Newborn
- Medical subject headings
- Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
Secondary outcomes (2)
Duration of analgesia during immunizations
Age related changes in behavioral pain response during immunizations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start1 Nov 2003
- Primary completion11 Oct 2006
- Study completion11 Oct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor
- Investigators
- Linda A Hatfield, PhD(c) CNNP, Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150189
- Sponsor's protocol ID
- IRB NO. 2003-315
- Status last verified
- Dec 2006
- First submitted
- 6 Sep 2005
- Last updated
- 25 May 2018
- Results posted
- No
Publications
Hatfield LA, Gusic ME, Dyer AM, Polomano RC. Analgesic properties of oral sucrose during routine immunizations at 2 and 4 months of age. Pediatrics. 2008 Feb;121(2):e327-34. doi: 10.1542/peds.2006-3719.
PubMed 18245406
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
- ClinicalTrials.gov ID
- NCT00150189
- Acronym / sponsor ID
- IRB NO. 2003-315
- Conditions
- Pain, Procedural Pain
- Keywords
- Pain, Procedural Pain, Sucrose, Infant, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- 1 Nov 2003 (actual)
- Primary completion
- 11 Oct 2006 (actual)
- Study completion
- 11 Oct 2006 (actual)
- First posted
- 8 Sep 2005 (estimated)
- 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 study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.
Detailed description
Acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. Immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. This study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. The proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn.
Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Currently between 2 and 4 months of age
- Birth between 37 and 42 weeks' completed gestation;
- Birth weight greater than 2.5 kg
- No evidence of acute or chronic disease processes.
Key exclusion criteria (7 listed)
- They are experiencing concurrent illness
- They received an analgesic/sedative 6 hours prior to the office visit
- The infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization
- The infant has been introduced to solid food
- The infant may not receive a pacifier
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 |
|---|---|---|
| Sucrose | Behavioural | – |
Primary outcome
The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
2 secondary outcomes
Duration of analgesia during immunizations
Age related changes in behavioral pain response during immunizations
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 25 May 2018.
- Derived from this study: PubMed 18245406Hatfield LA, Gusic ME, Dyer AM, Polomano RC. Analgesic properties of oral sucrose during routine immunizations at 2 and 4 months of age. Pediatrics. 2008 Feb;121(2):e327-34. doi: 10.1542/peds.2006-3719.
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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.
Linda A Hatfield, PhD(c) CNNP principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose in people with Pain and Procedural Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
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 4 inclusion and 7 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 25 May 2018. 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 United States. 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. 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?
The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00150189, which also lists 1 linked publication.
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 25 May 2018.