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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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