FastingNCT01949987
Does Oral Intake Decreases Postoperative Pain Score in Children
A study testing two hours and one hour in people with Fasting and Postoperative Pain, run by Ibaraki Children's Hospital at 1 site in Japan.
Trial summary
Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score. Read more about this study
- Who is it for?
- Ages 18 months to 12 years
- Conditions the study is for
- Fasting, Postoperative Pain
- What is being tested?
- two hours and one hour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2013to Oct 2014
- 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 18 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery
Who cannot join
- neurological disease, developmental delay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Intake on Pain Score in Children Undergoing Herniorrhaphy
Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score.
A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting.
The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.
- Conditions
- Fasting, Postoperative Pain
- Being tested
- two hours, one hour
- Medical subject headings
- Fasting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two hoursOther
one hourOther
| Study group | Role | What they receive |
|---|---|---|
| 2 hours after surgery | Active comparator | the investigators permit the patients to resume oral intake two hours after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability Receives: Other: two hours |
| 1 hour after surgery | Experimental | the investigators permit the patients to resume oral intake one hour after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability Receives: Other: one hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether oral intake influences postoperative pain score in children
pain degree is assessed using mCHEOPS and FLACC in young children, and using FPS-R in older (8 years or older) children
Measured: 90 minutes after surgery
Secondary outcomes (1)
postoperative nausea and vomiting
all children have to stay in hospital for 3 hours, and then, doctors visit the child and decide to discharge or not. Therefore, most of children stay in hospital approximately for 4 hours.
Measured: 4 hours on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibaraki Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuhiko Okuyama, MD, Ibaraki Children's Hospital
- Investigators
- Kazuhiko Okuyama, MD, Study director, Ibaraki Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949987
- Sponsor's protocol ID
- Pain and oral intake
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2013
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Intake on Pain Score in Children Undergoing Herniorrhaphy
- ClinicalTrials.gov ID
- NCT01949987
- Acronym / sponsor ID
- Pain and oral intake
- Conditions
- Fasting, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ibaraki Children's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- First posted
- 25 Sep 2013 (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.
Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score.
A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting.
The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 hours after surgery | Active comparator | Other: two hoursthe investigators permit the patients to resume oral intake two hours after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability |
| 1 hour after surgery | Experimental | Other: one hourthe investigators permit the patients to resume oral intake one hour after surgery and observe child's behavior and score; cry, facial expression, verbal expression, torso, legs, activity, and consolability |
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery
Key exclusion criteria (1 listed)
- neurological disease, developmental delay
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 |
|---|---|---|
| two hours | Other | 2 hours after surgery |
| one hour | Other | 1 hour after surgery |
Primary outcome
whether oral intake influences postoperative pain score in children
Time frame: 90 minutes after surgery
pain degree is assessed using mCHEOPS and FLACC in young children, and using FPS-R in older (8 years or older) children
1 secondary outcome
postoperative nausea and vomiting
Time frame: 4 hours on average
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 13 Sep 2016.
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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.
Kazuhiko Okuyama, MD study director
Ibaraki Children's 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 two hours and one hour in people with Fasting and Postoperative Pain, run by Ibaraki Children's Hospital at 1 site in Japan.
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 1 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 13 Sep 2016. 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 Japan. 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?
whether oral intake influences postoperative pain score in children (time frame: 90 minutes after surgery). 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 13 Sep 2016.