Intravenous Paracetamol for Postoperative Pain

NCT02248493 | Completed Phase 4

• 1 other identifier: BEC-MF-10
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively. Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.

Conditions

Pain, Postoperative; Recovery of Function; Child

Keywords

Pain, Postoperative; Paracetamol; Administration, Intravenous; Anti-Inflammatory Agents, Non-Steroidal; Child; Adolescent

Outcome Measures

Primary Outcomes (1)

• change in postoperative intravenous opioid dose

  24 hours postoperatively

Secondary Outcomes (2)

• change in pain level (analgesia) assessed by 10 point pain scales

  1 hour postoperatively

• change in pain level (analgesia) assessed by 10 point pain scales

  24 hours postoperatively

Other Outcomes (3)

• time until the first oral intake after surgery

  24 hours postoperatively

• time until the first urination after surgery

  24 hours postoperatively

• time until ambulation after surgery

  24 hours postoperatively

Study Arms (2)

paracetamol and ketoprofen

EXPERIMENTAL

paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.

Drug: Paracetamol; Drug: Ketoprofen; Drug: Tramadol; Drug: Morphine

placebo and ketoprofen

PLACEBO COMPARATOR

0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.

Drug: Placebo (for paracetamol); Drug: Ketoprofen; Drug: Tramadol; Drug: Morphine

Interventions

Paracetamol DRUG

Also known as: Acetaminophen

paracetamol and ketoprofen

Placebo (for paracetamol) DRUG

Also known as: 0.9% sodium cloride solution, Normal saline solution, Izotonic saline solution

placebo and ketoprofen

Ketoprofen DRUG

Also known as: Ketonal

paracetamol and ketoprofen; placebo and ketoprofen

Tramadol DRUG

Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.

Also known as: Tramal

paracetamol and ketoprofen; placebo and ketoprofen

Morphine DRUG

administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.

paracetamol and ketoprofen; placebo and ketoprofen

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients 1-18 years of age, undergoing general, plastic or orthopedic surgery with expected median to severe pain postoperatively.
• physical status of the patient corresponding to American Society of Anesthesiologists (ASA) class 1 or 2
• Signed written informed consent by parents/official caregivers.

You may not qualify if:

• Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
• oncologic disease
• central nervous system disease
• renal dysfunction
• hepatic dysfunction
• bronchial asthma
• ulcer(s) in gastrointestinal system
• hemorrhagic diathesis
• chronic use of NSAIDs
• chronic use of opioids
• chronic use of anticoagulants
• female patient is known to be pregnant

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Related Publications (4)

• Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.

  PMID: 20142348 BACKGROUND

• Wong I, St John-Green C, Walker SM. Opioid-sparing effects of perioperative paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) in children. Paediatr Anaesth. 2013 Jun;23(6):475-95. doi: 10.1111/pan.12163. Epub 2013 Apr 9.

  PMID: 23570544 BACKGROUND

• Hiller A, Silvanto M, Savolainen S, Tarkkila P. Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy. Acta Anaesthesiol Scand. 2004 Oct;48(9):1185-9. doi: 10.1111/j.1399-6576.2004.00473.x.

  PMID: 15352967 BACKGROUND

• Rugyte D, Kokki H. Intravenous ketoprofen as an adjunct to patient-controlled analgesia morphine in adolescents with thoracic surgery: a placebo controlled double-blinded study. Eur J Pain. 2007 Aug;11(6):694-9. doi: 10.1016/j.ejpain.2006.11.001. Epub 2006 Dec 20.

  PMID: 17185016 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Saline Solution; Ketoprofen; Tramadol; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Danguole C Rugyte, MD. PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: November 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

LI (1)