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Completed

NCT Number: NCT03352362

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

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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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain MedicineYonsei University College of Medicine Severance Hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 + 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

Primary outcomes

  1. 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

Secondary outcomes

  1. pain score (FLACC)

    Time frame: 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.

  2. pain score (FLACC)

    Time frame: Participant's pain score is evaluated by FLACC at 10 minutes after 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.

  3. pain score (FLACC)

    Time frame: Participant's pain score is evaluated by FLACC at 20 minutes after 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.

  4. 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)

    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.

  5. pain score (CHEOPS)

    Time frame: 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).

  6. pain score (CHEOPS)

    Time frame: Participant's pain score is evaluated by FLACC at 10 minutes after 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).

  7. pain score (CHEOPS)

    Time frame: Participant's pain score is evaluated by FLACC at 20 minutes after 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).

  8. 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)

    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).

  9. pain score (PPPM scale)

    Time frame: 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.

  10. pain score (PPPM scale)

    Time frame: The PPPM scale is measured at 12 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.

  11. pain score (PPPM scale)

    Time frame: 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.

  12. incidence of complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2017
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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