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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ibuprofen (caldolor 10 mg / kg)
propacetamol (denogan 30 mg / kg)
ibuprofen + propacetamol
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

6 Months - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

caldolor

denogan

combination

Arm Description

intravenous caldolor injection during intraoperative period

intravenous denogan injection during intraoperative period

intravenous denogan and caldolor injection during intraoperative period

Outcomes

Primary Outcome Measures

additional administration of analgesics
whether additional analgesics are administered during the postanesthesia care unit due to pain

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
incidence of complications
incidence of complications in PACU (postanesthesia care unit)

Full Information

First Posted
November 20, 2017
Last Updated
May 2, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03352362
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
Masking
Participant
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caldolor
Arm Type
Experimental
Arm Description
intravenous caldolor injection during intraoperative period
Arm Title
denogan
Arm Type
Active Comparator
Arm Description
intravenous denogan injection during intraoperative period
Arm Title
combination
Arm Type
Experimental
Arm Description
intravenous denogan and caldolor injection during intraoperative period
Intervention Type
Drug
Intervention Name(s)
ibuprofen (caldolor 10 mg / kg)
Intervention Description
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
Intervention Name(s)
propacetamol (denogan 30 mg / kg)
Intervention Description
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
Intervention Name(s)
ibuprofen + propacetamol
Intervention Description
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
Primary Outcome Measure Information:
Title
additional administration of analgesics
Description
whether additional analgesics are administered during the postanesthesia care unit due to pain
Time Frame
during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
Secondary Outcome Measure Information:
Title
pain score (FLACC)
Description
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.
Time Frame
Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
Title
pain score (FLACC)
Description
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.
Time Frame
Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
Title
pain score (FLACC)
Description
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.
Time Frame
Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
Title
pain score (FLACC)
Description
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.
Time Frame
Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour)
Title
pain score (CHEOPS)
Description
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).
Time Frame
Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
Title
pain score (CHEOPS)
Description
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).
Time Frame
Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
Title
pain score (CHEOPS)
Description
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).
Time Frame
Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
Title
pain score (CHEOPS)
Description
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).
Time Frame
Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour)
Title
pain score (PPPM scale)
Description
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.
Time Frame
The PPPM scale is measured at 4 hours after surgery
Title
pain score (PPPM scale)
Description
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.
Time Frame
The PPPM scale is measured at 12 hours after surgery
Title
pain score (PPPM scale)
Description
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.
Time Frame
The PPPM scale is measured at 24 hours after surgery
Title
incidence of complications
Description
incidence of complications in PACU (postanesthesia care unit)
Time Frame
during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33181557
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.
Results Reference
derived

Learn more about this trial

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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