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

NCT03352362 | Completed

• 1 other identifier: 4-2017-0869
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• pain score (FLACC)

  Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)

• pain score (FLACC)

  Participant's pain score is evaluated by FLACC at 10 minutes after arriving the postanesthesia care unit(PACU)

• pain score (FLACC)

  Participant's pain score is evaluated by FLACC at 20 minutes after arriving the postanesthesia care unit(PACU)

• 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)

• pain score (CHEOPS)

  Participant's pain score is evaluated by FLACC at the time of arriving the postanesthesia care unit(PACU)

Study Arms (3)

caldolor

EXPERIMENTAL

intravenous caldolor injection during intraoperative period

Drug: ibuprofen (caldolor 10 mg / kg)

denogan

ACTIVE COMPARATOR

intravenous denogan injection during intraoperative period

Drug: propacetamol (denogan 30 mg / kg)

combination

EXPERIMENTAL

intravenous denogan and caldolor injection during intraoperative period

Drug: ibuprofen + propacetamol

Interventions

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

caldolor

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

denogan

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

combination

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• scheduled to undergo laparoscopic inguinal hernia surgery
• American Society of Anesthesiologists physical status classification 1 or 2
• Children aged 6 months to 6 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33181557 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Ibuprofen; propacetamol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: December 15, 2017
• Primary Completion: March 8, 2019
• Study Completion: March 9, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)