Clinical trial NCT03352362: Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Official title: Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 159
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: additional administration of analgesics
timeFrame: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
Secondary outcomes:
measure: pain score (FLACC)
timeFrame: Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
measure: pain score (FLACC)
timeFrame: Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
measure: pain score (FLACC)
timeFrame: Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
measure: pain score (FLACC)
timeFrame: Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour)
measure: pain score (CHEOPS)
timeFrame: Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
measure: pain score (CHEOPS)
timeFrame: Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
measure: pain score (CHEOPS)
timeFrame: Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
measure: pain score (CHEOPS)
timeFrame: Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour)
measure: pain score (PPPM scale)
timeFrame: The PPPM scale is measured at 4 hours after surgery
measure: pain score (PPPM scale)
timeFrame: The PPPM scale is measured at 12 hours after surgery
measure: pain score (PPPM scale)
timeFrame: The PPPM scale is measured at 24 hours after surgery
measure: incidence of complications
timeFrame: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital
Study officials:
References:
citation: Lee HM, Park JH, Park SJ, Choi H, Lee JR. Comparison of Monotherapy Versus Combination of Intravenous Ibuprofen and Propacetamol (Acetaminophen) for Reduction of Postoperative Opioid Administration in Children Undergoing Laparoscopic Hernia Repair: A Double-Blind Randomized Controlled Trial. Anesth Analg. 2021 Jul 1;133(1):168-175. doi: 10.1213/ANE.0000000000005284.