The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Procare Riaya Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- ED50s of Paracetamol, morphine and their combination
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
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
Intervention: Paracetamol (Drug)
Morphine
Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg .
Intervention: 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.
Intervention: Paracetamol- Morphine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Paracetamol-Morphine interaction nature(participants will be followed for the duration of hospital stay, an expected average of 8 weeks)
Investigators
Ahed ZEIDAN
MD
Procare Riaya Hospital