Does Oral Intake Decreases Postoperative Pain Score in Children

September 9, 2016 updated by: Kazuhiko Okuyama, MD, Ibaraki Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • neurological disease, developmental delay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 minutes after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative nausea and vomiting
Time Frame: 4 hours on average
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.
4 hours on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibaraki Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pain and oral intake

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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