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NCT Number: NCT01366313

The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Procare Riaya Hospital

Khobar, Estern, 31952, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Paracetamol

Drug

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 names: Perfalgan

Morphine

Drug

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

Other names: Morphine sulfate

Paracetamol- Morphine

Drug

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 names: Perfalgan-Morphine

Primary outcomes

  1. 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

  1. Paracetamol-Morphine interaction nature

    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.

Sponsors and collaborators

Lead sponsor

Procare Riaya Hospital

Other

Registry information

Official study title

The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2011
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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