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

NCT ID: NCT01366313

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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

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Postoperative Pain

Keywords

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paracetamol morphine median effective dose pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Paracetamol

Intervention Type 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

Morphine

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Paracetamol- Morphine

Intervention Type 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.

Interventions

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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

Intervention Type DRUG

Morphine

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

Intervention Type 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 Type DRUG

Other Intervention Names

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Perfalgan Morphine sulfate Perfalgan-Morphine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. contraindication to the use of paracetamol and morphine
2. Pregnancy
3. age younger than 18 yr
4. patient weight less 65kg
5. intra-operative regional anesthesia,
6. intra-operative administration of analgesics other than fentanyl,
7. postoperative pain less than 3 on a numerical pain score (NPS)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Procare Riaya Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahed ZEIDAN

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AHED ZEIDAN, MD

Role: STUDY_CHAIR

Procare Riaya Hospital

Locations

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Procare Riaya Hospital

Khobar, Estern, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 24157897 (View on PubMed)

Other Identifiers

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PRH 02

Identifier Type: -

Identifier Source: org_study_id