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

Yonsei University

Status: Completed

Conditions: Inguinal Hernia

Treatments: Drug: ibuprofen + propacetamol; Drug: propacetamol (denogan 30 mg / kg); Drug: ibuprofen (caldolor 10 mg / kg)

Study type: Interventional

Funder types: Other

Identifiers

NCT03352362

4-2017-0869

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 3 patient groups

caldolor

Experimental group

Description:

intravenous caldolor injection during intraoperative period

Treatment:

Drug: ibuprofen (caldolor 10 mg / kg)

denogan

Active Comparator group

Description:

intravenous denogan injection during intraoperative period

Treatment:

Drug: propacetamol (denogan 30 mg / kg)

combination

Experimental group

Description:

intravenous denogan and caldolor injection during intraoperative period

Treatment:

Drug: ibuprofen + propacetamol