NCT01366313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

December 10, 2012

Status Verified

January 1, 2011

Enrollment Period

3.5 years

First QC Date

June 2, 2011

Last Update Submit

December 7, 2012

Conditions

Postoperative Pain

Keywords

paracetamolmorphinemedian effective dosepain

Outcome Measures

Primary Outcomes (1)

  • 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.

    participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Secondary Outcomes (1)

  • Paracetamol-Morphine interaction nature

    participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Study Arms (3)

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

Drug: Paracetamol

Morphine

EXPERIMENTAL

Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg .

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.

Drug: Paracetamol- Morphine

Interventions

ParacetamolDRUG

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

Also known as: Perfalgan
Paracetamol
MorphineDRUG

Initial of morphine was 5mg, with dose adjustment intervals 1 mg .

Also known as: Morphine sulfate
Morphine
Paracetamol- MorphineDRUG

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.

Also known as: Perfalgan-Morphine
Paracetamol-morphine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status І or ІІ
  • Moderately painful surgery patients
  • postoperative pain more than 3 on a numerical pain score (NPS) -

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Procare Riaya Hospital

Khobar, Estern, 31952, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 24157897DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

AcetaminophenMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • AHED ZEIDAN, MD

    Procare Riaya Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 10, 2012

Record last verified: 2011-01

Locations

SA(1)