NCT01949987

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 9, 2013

Last Update Submit

September 9, 2016

Conditions

FastingPostoperative Pain

Outcome Measures

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

    90 minutes after surgery

Secondary Outcomes (1)

  • postoperative nausea and vomiting

    4 hours on average

Study Arms (2)

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

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

Other: one hour

Interventions

two hoursOTHER
2 hours after surgery
one hourOTHER
1 hour after surgery

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • neurological disease, developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibaraki Children's Hospital

Mito, Ibaraki, 311-4145, Japan

Location

MeSH Terms

Conditions

FastingPain, Postoperative

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Kazuhiko Okuyama, MD

    Ibaraki Children's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief anesthesiologist

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 25, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

JP(1)