Inguinal HerniaNCT03352362
Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
A study testing ibuprofen (caldolor 10 mg / kg), propacetamol (denogan 30 mg / kg) and ibuprofen + propacetamol in people with Inguinal Hernia, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- ibuprofen (caldolor 10 mg / kg), propacetamol (denogan 30 mg / kg) and ibuprofen + propacetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2017to 9 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- scheduled to undergo laparoscopic inguinal hernia surgery
- American Society of Anesthesiologists physical status classification 1 or 2
- Children aged 6 months to 6 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital
Seoul, 03722
About this study
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.
- Conditions
- Inguinal Hernia
- Being tested
- ibuprofen (caldolor 10 mg / kg), propacetamol (denogan 30 mg / kg), ibuprofen + propacetamol
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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 + propacetamolDrug
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
| Study group | Role | What they receive |
|---|---|---|
| caldolor | Experimental | intravenous caldolor injection during intraoperative period Receives: Drug: ibuprofen (caldolor 10 mg / kg) |
| denogan | Active comparator | intravenous denogan injection during intraoperative period Receives: Drug: propacetamol (denogan 30 mg / kg) |
| combination | Experimental | intravenous denogan and caldolor injection during intraoperative period Receives: Drug: ibuprofen + propacetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
additional administration of analgesics
whether additional analgesics are administered during the postanesthesia care unit due to pain
Measured: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
Secondary outcomes (12)
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.
Measured: Participant's pain score is evaluated by FLACC at the time of 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The PPPM scale is measured at 24 hours after surgery
incidence of complications
incidence of complications in PACU (postanesthesia care unit)
Measured: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start15 Dec 2017
- Primary completion8 Mar 2019
- Study completion9 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352362
- Sponsor's protocol ID
- 4-2017-0869
- Status last verified
- May 2019
- First submitted
- 20 Nov 2017
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33181557
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03352362
- Acronym / sponsor ID
- 4-2017-0869
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
| Arm | Type | Receives |
|---|---|---|
| caldolor | Experimental | Drug: ibuprofen (caldolor 10 mg / kg)intravenous caldolor injection during intraoperative period |
| denogan | Active comparator | Drug: propacetamol (denogan 30 mg / kg)intravenous denogan injection during intraoperative period |
| combination | Experimental | Drug: ibuprofen + propacetamolintravenous denogan and caldolor injection during intraoperative period |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- scheduled to undergo laparoscopic inguinal hernia surgery
- American Society of Anesthesiologists physical status classification 1 or 2
- Children aged 6 months to 6 years
Key exclusion criteria (7 listed)
- history of Gastrointestinal bleeding
- history or laboratory finding of suspected renal or hepatic dysfunction
- bronchial asthma
- bleeding disorder
- hypersensitivity to NSAID or propacetamol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | caldolor |
| 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 | Drug | denogan |
| ibuprofen + propacetamolDilution 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 | Drug | combination |
Primary outcome
additional administration of analgesics
Time frame: 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
12 secondary outcomes
pain score (FLACC)
Time frame: Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
pain score (FLACC)
Time frame: Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
pain score (FLACC)
Time frame: Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
pain score (FLACC)
Time frame: 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)
Time frame: Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)
pain score (CHEOPS)
Time frame: Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)
pain score (CHEOPS)
Time frame: Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)
pain score (CHEOPS)
Time frame: 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)
Time frame: The PPPM scale is measured at 4 hours after surgery
pain score (PPPM scale)
Time frame: The PPPM scale is measured at 12 hours after surgery
pain score (PPPM scale)
Time frame: The PPPM scale is measured at 24 hours after surgery
incidence of complications
Time frame: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Derived from this study: PubMed 33181557Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ibuprofen (caldolor 10 mg / kg), propacetamol (denogan 30 mg / kg) and ibuprofen + propacetamol in people with Inguinal Hernia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
additional administration of analgesics (time frame: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.