Does Oral Intake Decreases Postoperative Pain Score in Children

Not Applicable

Completed

• Conditions: Postoperative Pain; Fasting
• Interventions: Other: two hours; Other: one hour

• Registration Number: NCT01949987
• Lead Sponsor: Ibaraki Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-25
• Study Start: 2013-10
• Primary Completion: 2014-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• neurological disease, developmental delay

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 hours after surgery	two hours	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
1 hour after surgery	one hour	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

Primary Outcome Measures

Name	Time	Method
whether oral intake influences postoperative pain score in children	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

Secondary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	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.

Trial Locations

Locations (1)

Ibaraki Children's Hospital; 🇯🇵 Mito, Ibaraki, Japan