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CompletedNCT01949987Updated Sep 13, 2016

Does Oral Intake Decreases Postoperative Pain Score in Children

An interventional study of two hours and one hour in Fasting and Postoperative Pain, sponsored by Ibaraki Children's Hospital. Completed at 1 site in Japan. Open to participants aged 18 Months to 12 Years. Per ClinicalTrials.gov, last updated 2016-09-13.

Sponsored by Ibaraki Children's Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Months to 12 Years
Sex
All
01

Study 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.

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.

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Conditions studied

  • Fasting
  • Postoperative Pain
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In context

Fasting

86 studies on the registry are indexed under Fasting; 38 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 66 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Ibaraki Children's Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery

Exclusion criteria

Exclusion Criteria:

  • neurological disease, developmental delay
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    2 hours after surgery

    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

    Other: two hours

  • Experimental
    1 hour after surgery

    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

    Other: one hour

Interventions

  • Othertwo hours
  • Otherone hour
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 4 hours on average

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Study locations

1 site
  • Ibaraki Children's Hospital
    Mito, Ibaraki 311-4145, Japan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01949987
Lead sponsor
Ibaraki Children's Hospital
Responsible party
Kazuhiko Okuyama, MD (Chief anesthesiologist, Ibaraki Children's Hospital) — Principal investigator
First posted
Sep 25, 2013
Start date
Oct 2013
Primary completion
Oct 2014
Last update
Sep 13, 2016

Study contacts

Kazuhiko Okuyama, MD
study director · Ibaraki Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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