The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study
Information source: Procare Riaya Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Paracetamol (Drug); Morphine (Drug); Paracetamol- Morphine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Procare Riaya Hospital Official(s) and/or principal investigator(s): AHED ZEIDAN, MD, Study Chair, Affiliation: Procare Riaya Hospital
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.
Clinical Details
Official title: The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ED50s of Paracetamol, morphine and their combination
Secondary outcome: Paracetamol-Morphine interaction nature
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Procare Riaya Hospital, Al Khobar, Estern 31952, Saudi Arabia
Additional Information
Starting date: September 2007
Last updated: December 7, 2012
|