TerminatedPhase 4ACTRN12609000915257

Do the post operative nausea and vomiting (PONV) drugs Granisetron and Ondansetron negate the analgesic effects of Paracetamol?

Do the post operative nausea and vomiting (PONV) drugs Granisetron and Ondansetron negate the analgesic effects of Paracetamol in healthy male volunteers?


Sponsor

Dr Paul Sherwin

Enrollment

40 participants

Start Date

Oct 20, 2009

Study Type

Interventional

Conditions

Summary

12/11/2009. A pilot study checking the sensitivity of the Painmatcher is currently underway. This involves 20 healthy male volunteers who are randomised to receive either 100mls Normal Saline intravenously or 1g Paracetamol intravenously in a blinded crossover fashion. Pain thresholds are checked using the PainMatcher at T0, T30, T60, T120, T180, T240. Each volunteer has been trained four times prior to the first clinical session in the use of the PainMatcher. 18/07/2010. The pilot study has now been completed.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether two common anti-nausea medications (granisetron and ondansetron) interfere with the pain-relieving effects of paracetamol. It is for healthy males aged 18 to 55 who are not taking any prescription medications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Volunteers will be cannulated and a baseline pain threshold measured using a "PainMatcher". Volunteers will receive either Granisetron 1mg intravenously (iv), ondansetron 4mg intravenously (iv) or 5ml

Volunteers will be cannulated and a baseline pain threshold measured using a "PainMatcher". Volunteers will receive either Granisetron 1mg intravenously (iv), ondansetron 4mg intravenously (iv) or 5mls normal saline intravenously (iv) (placebo). 30 minutes later (time T 0) pain threshold will be measured followed by administration of paracetamol 1g intravenously (iv) and decannulation. Pain thresholds will be measured at T30, T60, T120, T180 and T240 using the "PainMatcher". The trial is fully randomised and double blinded. Each volunteer will attend 3 clinical sessions spaced one week apart so that they receive all three medications in a crossover fashion.


Locations(1)

Australia

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ACTRN12609000915257


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