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
About this trial
This is an interventional treatment trial for Inguinal Hernia
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.
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
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
We'll reach out to this number within 24 hrs