Postoperative PainNCT01366313
The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study
A study testing Paracetamol, Morphine and Paracetamol- Morphine in people with Postoperative Pain, run by Procare Riaya Hospital at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paracetamol, Morphine and Paracetamol- Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status І or ІІ
- Moderately painful surgery patients
- postoperative pain more than 3 on a numerical pain score (NPS) -
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Paracetamol, Morphine, Paracetamol- Morphine
- Keywords
- paracetamol, morphine, median effective dose, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
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
MorphineDrug
Also called Morphine sulfate
Initial of morphine was 5mg, with dose adjustment intervals 1 mg .
Paracetamol- MorphineDrug
Also called Perfalgan-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.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | 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 Receives: Drug: Paracetamol |
| Morphine | Experimental | Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg . Receives: Drug: Morphine |
| Paracetamol-morphine | Experimental | 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. Receives: Drug: Paracetamol- Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary outcomes (1)
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Riaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahed ZEIDAN, Procare Riaya Hospital
- Investigators
- AHED ZEIDAN, MD, Study chair, Procare Riaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366313
- Sponsor's protocol ID
- PRH 02
- Status last verified
- Jan 2011
- First submitted
- 2 Jun 2011
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24157897
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
- ClinicalTrials.gov ID
- NCT01366313
- Acronym / sponsor ID
- PRH 02
- Conditions
- Postoperative Pain
- Keywords
- paracetamol, morphine, median effective dose, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Procare Riaya HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: Paracetamolinitial 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 |
| Morphine | Experimental | Drug: MorphineInitial doses of morphine was 5mg, with dose adjustment intervals of 1 mg . |
| Paracetamol-morphine | Experimental | Drug: Paracetamol- MorphineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status І or ІІ
- Moderately painful surgery patients
- postoperative pain more than 3 on a numerical pain score (NPS) -
Key exclusion criteria (7 listed)
- contraindication to the use of paracetamol and morphine
- Pregnancy
- age younger than 18 yr
- patient weight less 65kg
- intra-operative regional anesthesia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Perfalganinitial doses was 1.5g, with dose adjustment intervals of 0.5g . with maximum dose 2.5 g as an only starting dose / 24 h | Drug | Paracetamol |
| MorphineAlso: Morphine sulfateInitial of morphine was 5mg, with dose adjustment intervals 1 mg . | Drug | Morphine |
| Paracetamol- MorphineAlso: Perfalgan-MorphineThe 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 |
Primary outcome
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.
1 secondary outcome
Paracetamol-Morphine interaction nature
Time frame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
- Derived from this study: PubMed 24157897Zeidan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHED ZEIDAN, MD study chair
Procare Riaya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol, Morphine and Paracetamol- Morphine in people with Postoperative Pain, run by Procare Riaya Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.