Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-03-09

Brief Summary

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There are difficulties in the progress of the study and cancel the plan. The purpose of this study is to evaluate the postoperative pain control using non - opioidal analgesics in children. The investigators will investigate the effect of single use and combination of caldorol(ibuprofen) compare to denogan(propacetamol) in children.

Participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years old are divided 3 groups(caldolor, denogan, combination). Each groups are received a medication by protocol during surgery. After operation patient's pain score and use of additional analgesics are recorded in postanesthesia care unit and general ward.

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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caldolor

intravenous caldolor injection during intraoperative period

Group Type EXPERIMENTAL

ibuprofen (caldolor 10 mg / kg)

Intervention Type DRUG

Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia

denogan

intravenous denogan injection during intraoperative period

Group Type ACTIVE_COMPARATOR

propacetamol (denogan 30 mg / kg)

Intervention Type DRUG

Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end

combination

intravenous denogan and caldolor injection during intraoperative period

Group Type EXPERIMENTAL

ibuprofen + propacetamol

Intervention Type DRUG

Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end

Interventions

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ibuprofen (caldolor 10 mg / kg)

Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia

Intervention Type DRUG

propacetamol (denogan 30 mg / kg)

Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end

Intervention Type DRUG

ibuprofen + propacetamol

Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* scheduled to undergo laparoscopic inguinal hernia surgery
* American Society of Anesthesiologists physical status classification 1 or 2
* Children aged 6 months to 6 years

Exclusion Criteria

* history of Gastrointestinal bleeding
* history or laboratory finding of suspected renal or hepatic dysfunction
* bronchial asthma
* bleeding disorder
* hypersensitivity to NSAID or propacetamol
* disagreement of investigation
* The researcher determines that participation is inappropriate due to other reasons.

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No