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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352362
• Other study ID #: 4-2017-0869
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: March 9, 2019

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: March 9, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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