Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
- Conditions
- Inguinal Hernia
- Interventions
- Registration Number
- NCT03352362
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- scheduled to undergo laparoscopic inguinal hernia surgery
- American Society of Anesthesiologists physical status classification 1 or 2
- Children aged 6 months to 6 years
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description denogan propacetamol (denogan 30 mg / kg) intravenous denogan injection during intraoperative period caldolor ibuprofen (caldolor 10 mg / kg) intravenous caldolor injection during intraoperative period combination ibuprofen + propacetamol intravenous denogan and caldolor injection during intraoperative period
- Primary Outcome Measures
Name Time Method additional administration of analgesics during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour whether additional analgesics are administered during the postanesthesia care unit due to pain
- Secondary Outcome Measures
Name Time Method pain score (FLACC) Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour) 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) Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour) 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) The PPPM scale is measured at 24 hours after surgery 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 during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour incidence of complications in PACU (postanesthesia care unit)
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital
🇰🇷Seoul, Korea, Republic of