Inguinal Hernia
Conditions
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.
Interventions
DRUGibuprofen (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
DRUGpropacetamol (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
DRUGibuprofen + 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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| pain score (FLACC) | Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU) | 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 arriving the postanesthesia care unit(PACU) | 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 4 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) |
Countries
South Korea
Outcome results
None listed