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

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Drug: ibuprofen (caldolor 10 mg / kg); Drug: propacetamol (denogan 30 mg / kg); Drug: ibuprofen + propacetamol

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: caldolor; intravenous caldolor injection during intraoperative period	Drug: 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
Active Comparator: denogan; intravenous denogan injection during intraoperative period	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
Experimental: combination; intravenous denogan and caldolor injection during intraoperative period	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
additional administration of analgesics	whether additional analgesics are administered during the postanesthesia care unit due to pain	during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score (FLACC)	Face-legs-activity-cry-consolability scale(FLACC) - FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
pain score (FLACC)	Face-legs-activity-cry-consolability scale(FLACC) - FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
pain score (FLACC)	Face-legs-activity-cry-consolability scale(FLACC) - FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
pain score (FLACC)	Face-legs-activity-cry-consolability scale(FLACC) - FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour)
pain score (CHEOPS)	Children's Hospital of Eastern Ontario Pain Scale(CHEOPS) - The CHEOPS is an observational scale for measuring postoperative pain in children aged 1-7 years. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).	Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
pain score (CHEOPS)	Children's Hospital of Eastern Ontario Pain Scale(CHEOPS) - The CHEOPS is an observational scale for measuring postoperative pain in children aged 1-7 years. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).	Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
pain score (CHEOPS)	Children's Hospital of Eastern Ontario Pain Scale(CHEOPS) - The CHEOPS is an observational scale for measuring postoperative pain in children aged 1-7 years. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).	Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
pain score (CHEOPS)	Children's Hospital of Eastern Ontario Pain Scale(CHEOPS) - The CHEOPS is an observational scale for measuring postoperative pain in children aged 1-7 years. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).	Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour)
pain score (PPPM scale)	Parents' Postoperative Pain Measure(PPPM scale): The number of items parents have circled "Yes" are summed for a total score out of 15. A score of at least 6 out of 15 signifies clinically significant pain.	The PPPM scale is measured at 4 hours after surgery
pain score (PPPM scale)	Parents' Postoperative Pain Measure(PPPM scale): The number of items parents have circled "Yes" are summed for a total score out of 15. A score of at least 6 out of 15 signifies clinically significant pain.	The PPPM scale is measured at 12 hours after surgery
pain score (PPPM scale)	Parents' Postoperative Pain Measure(PPPM scale): The number of items parents have circled "Yes" are summed for a total score out of 15. A score of at least 6 out of 15 signifies clinically significant pain.	The PPPM scale is measured at 24 hours after surgery
incidence of complications	incidence of complications in PACU (postanesthesia care unit)	during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 9, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen; Propacetamol
• Other Study ID Numbers: 4-2017-0869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No