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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahed ZEIDAN, Procare Riaya Hospital
ClinicalTrials.gov Identifier:
NCT01366313
First received: June 2, 2011
Last updated: December 7, 2012
Last verified: January 2011
  Purpose

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 Intervention
Postoperative Pain
Drug: Paracetamol
Drug: Morphine
Drug: Paracetamol- Morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.

Resource links provided by NLM:


Further study details as provided by Procare Riaya Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366313

Locations
Saudi Arabia
Procare Riaya Hospital
Al Khobar, Estern, Saudi Arabia, 31952
Sponsors and Collaborators
Procare Riaya Hospital
Investigators
Study Chair: AHED ZEIDAN, MD Procare Riaya Hospital
  More Information

No publications provided by Procare Riaya Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ahed ZEIDAN, MD, Procare Riaya Hospital
ClinicalTrials.gov Identifier: NCT01366313     History of Changes
Other Study ID Numbers: PRH 02
Study First Received: June 2, 2011
Last Updated: December 7, 2012
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by Procare Riaya Hospital:
paracetamol
morphine
median effective dose
pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Morphine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014