Procedural PainNCT00446875
Analgesic Properties of Oral Sucrose During Immunizations
A study testing Administration of oral Sucrose in people with Procedural Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations. Read more about this study
- Who is it for?
- Ages 3 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Administration of oral Sucrose
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 19 May 2008
- 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 3 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Currently between 4 and 11 months of age;
- Between 37 and 42 weeks' completed gestation at birth;
- Birth weight greater than 2.5 kg; and
- No evidence of acute or chronic disease
Who cannot join
- Fed 30 minutes prior to immunization;
- Received analgesic/sedative the day of the immunizations;
- Parent wishes to feed the infant during the immunizations;
- Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
- Language barriers preclude the process of obtaining parental consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Pediatric Associates, Penn State Children's Hospital
Hershey, Pennsylvania, 17033
About this study
Official title: Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.
Read the detailed description
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.
Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.
Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.
- Conditions
- Procedural Pain
- Being tested
- Administration of oral Sucrose, Administration of oral Placebo
- Keywords
- Pain, Procedural pain, Sucrose, Infant
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of oral SucroseOther
Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
Administration of oral PlaceboOther
Also called sterile water
Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. Receives: Other: Administration of oral Sucrose |
| Placebo | Placebo comparator | Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. Receives: Other: Administration of oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral pain response
Infants will be evaluated based on the University of Wisconsin Children's Hospital Pain Scale to score an infant's pain. Possible scores range from 0 (no pain) to 5 (worst possible pain).
Measured: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJan 2007
- Primary completion19 May 2008
- Study completion19 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda A Hatfield, PhD, Principal investigator, The Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446875
- Sponsor's protocol ID
- SeedHatfield
- Status last verified
- Feb 2019
- First submitted
- 9 Mar 2007
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
- ClinicalTrials.gov ID
- NCT00446875
- Acronym / sponsor ID
- SeedHatfield
- Conditions
- Procedural Pain
- Keywords
- Pain, Procedural pain, Sucrose, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- 19 May 2008 (actual)
- Study completion
- 19 May 2008 (actual)
- First posted
- 13 Mar 2007 (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 purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.
Detailed description
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.
Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.
Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Other: Administration of oral SucroseParticipants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. |
| Placebo | Placebo comparator | Other: Administration of oral PlaceboParticipants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine. |
Who may qualify
- Ages
- 3 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Currently between 4 and 11 months of age;
- Between 37 and 42 weeks' completed gestation at birth;
- Birth weight greater than 2.5 kg; and
- No evidence of acute or chronic disease
Key exclusion criteria (5 listed)
- Fed 30 minutes prior to immunization;
- Received analgesic/sedative the day of the immunizations;
- Parent wishes to feed the infant during the immunizations;
- Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
- Language barriers preclude the process of obtaining parental consent.
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 |
|---|---|---|
| Administration of oral SucroseParticipants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine. | Other | Sucrose |
| Administration of oral PlaceboAlso: sterile waterParticipants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine. | Other | Placebo |
Primary outcome
Behavioral pain response
Time frame: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine
Infants will be evaluated based on the University of Wisconsin Children's Hospital Pain Scale to score an infant's pain. Possible scores range from 0 (no pain) to 5 (worst possible pain).
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 15 Feb 2019.
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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 principal investigator
The Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of oral Sucrose in people with 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 5 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 15 Feb 2019. 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. 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?
Behavioral pain response (time frame: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine). 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 15 Feb 2019.