The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study
This study has been completed.
Sponsor:
Procare Riaya Hospital
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
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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:
- 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)
Contacts and Locations More Information
No publications provided
| 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 May 19, 2013