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The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01366313
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Ahed ZEIDAN, Procare Riaya Hospital

Study Description
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Brief Summary:
The aim of our study is to define the median effective analgesic doses (ED50) of paracetamol, morphine, and their combination and determination the nature of their interaction administered IV for postoperative pain after moderate painful surgery using up-and-down and isobolographic methods.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Paracetamol Drug: Morphine Drug: Paracetamol- Morphine Not Applicable

Detailed Description:
Ninety patients scheduled to undergo moderately painful surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses were 1.5g and 5mg, with dose adjustment intervals of 0.5g and 1 mg, in the paracetamol and morphine groups, respectively. The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine. Analgesic efficacy was defined as a decrease to less than 3 on a 0-10 numeric pain scale, 45 min after the beginning of drug administration. Isobolographic analysis was used to define the nature of their interaction.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
Study Start Date : September 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Paracetamol
initial doses was 1.5g g, with dose adjustment intervals of 0.5g . with maximum dose 2.5 g as an only starting dose / 24 h
 Drug: Paracetamol
initial doses was 1.5g, with dose adjustment intervals of 0.5g . with maximum dose 2.5 g as an only starting dose / 24 h
Other Name: Perfalgan
Experimental: Morphine
Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg .
 Drug: Morphine
Initial of morphine was 5mg, with dose adjustment intervals 1 mg .
Other Name: Morphine sulfate
Experimental: Paracetamol-morphine
The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine.
 Drug: Paracetamol- Morphine
The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine.
Other Name: Perfalgan-Morphine


Outcome Measures
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Primary Outcome Measures :
  1. ED50s of Paracetamol, morphine and their combination [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
    the aim of our study is to define the median effective analgesic doses (ED50s) of paracetamol, morphine, and their combination to determine the nature of their interaction administered IV for postoperative moderately painful surgery using the Dixon and Mood up-and-down method and isobolographic analysis.


Secondary Outcome Measures :
  1. Paracetamol-Morphine interaction nature [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
    the aim of our study is to define the median effective analgesic doses (ED50s) of paracetamol, morphine, and their combination to determine the nature of their interaction administered IV for postoperative moderately painful surgery using the Dixon and Mood up-and-down method and isobolographic analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA physical status І or ІІ
  2. Moderately painful surgery patients
  3. postoperative pain more than 3 on a numerical pain score (NPS) -

Exclusion Criteria:

  1. contraindication to the use of paracetamol and morphine
  2. Pregnancy
  3. age younger than 18 yr
  4. patient weight less 65kg
  5. intra-operative regional anesthesia,
  6. intra-operative administration of analgesics other than fentanyl,
  7. postoperative pain less than 3 on a numerical pain score (NPS)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366313


Locations
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Saudi Arabia
Procare Riaya Hospital
Al Khobar, Estern, Saudi Arabia, 31952
Sponsors and Collaborators
Procare Riaya Hospital
Investigators
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Study Chair: AHED ZEIDAN, MD Procare Riaya Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ahed ZEIDAN, MD, Procare Riaya Hospital
ClinicalTrials.gov Identifier: NCT01366313    
Other Study ID Numbers: PRH 02
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: January 2011
Keywords provided by Ahed ZEIDAN, Procare Riaya Hospital:
paracetamol
morphine
median effective dose
pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Morphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics