Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

April 30, 2014

Study Completion Date

May 31, 2014

Conditions
Postoperative Pain
Interventions
DRUG

Fentanyl

The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS \> 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.

DRUG

Morphine

The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS \> 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.

Trial Locations (1)

05001000

Antioquia University, Medellín

All Listed Sponsors
lead

Universidad de Antioquia

OTHER

NCT02145975 - Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine | Biotech Hunter | Biotech Hunter