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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366313
• Other study ID #: PRH 02
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: December 7, 2012
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: January 2011
• Source: Procare Riaya Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ASA physical status ? or ??

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• Morphine
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.

Locations

Country	Name	City	State
Saudi Arabia	Procare Riaya Hospital	Al Khobar	Estern

Sponsors (1)

Lead Sponsor	Collaborator
Procare Riaya Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	participants will be followed for the duration of hospital stay, an expected average of 8 weeks	No