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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Paracetamol
Morphine
Paracetamol- Morphine
Sponsored by
Procare Riaya Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring paracetamol, morphine, median effective dose, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Procare Riaya Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Paracetamol

Morphine

Paracetamol-morphine

Arm Description

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

Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg .

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.

Outcomes

Primary Outcome Measures

ED50s of Paracetamol, morphine and their combination
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

Paracetamol-Morphine interaction nature
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.

Full Information

First Posted
June 2, 2011
Last Updated
December 7, 2012
Sponsor
Procare Riaya Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01366313
Brief Title
The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study
Official Title
The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Procare Riaya Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
paracetamol, morphine, median effective dose, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
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
Arm Title
Morphine
Arm Type
Experimental
Arm Description
Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg .
Arm Title
Paracetamol-morphine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine sulfate
Intervention Description
Initial of morphine was 5mg, with dose adjustment intervals 1 mg .
Intervention Type
Drug
Intervention Name(s)
Paracetamol- Morphine
Other Intervention Name(s)
Perfalgan-Morphine
Intervention Description
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.
Primary Outcome Measure Information:
Title
ED50s of Paracetamol, morphine and their combination
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary Outcome Measure Information:
Title
Paracetamol-Morphine interaction nature
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status І or ІІ Moderately painful surgery patients postoperative pain more than 3 on a numerical pain score (NPS) - Exclusion Criteria: contraindication to the use of paracetamol and morphine Pregnancy age younger than 18 yr patient weight less 65kg intra-operative regional anesthesia, intra-operative administration of analgesics other than fentanyl, postoperative pain less than 3 on a numerical pain score (NPS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHED ZEIDAN, MD
Organizational Affiliation
Procare Riaya Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Procare Riaya Hospital
City
Al Khobar
State/Province
Estern
ZIP/Postal Code
31952
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24157897
Citation
Zeidan A, Mazoit JX, Ali Abdullah M, Maaliki H, Ghattas T, Saifan A. Median effective dose (ED(5)(0)) of paracetamol and morphine for postoperative pain: a study of interaction. Br J Anaesth. 2014 Jan;112(1):118-23. doi: 10.1093/bja/aet306. Epub 2013 Oct 24.
Results Reference
derived

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

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