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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caldolor | Experimental | intravenous caldolor injection during intraoperative period |
|
| denogan | Active Comparator | intravenous denogan injection during intraoperative period |
|
| combination | Experimental | intravenous denogan and caldolor injection during intraoperative period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen (caldolor 10 mg / kg) | Drug | Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33181557 | Derived | 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. |
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Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
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| propacetamol (denogan 30 mg / kg) | Drug | 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 | Drug | 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 |
|
| 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 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| C063776 | propacetamol |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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