Effects of Tapentadol Versus Oxycodone After Hysterectomy.

PHASE4CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

December 4, 2017

Primary Completion Date

February 28, 2019

Study Completion Date

February 28, 2019

Conditions
Pain, PostoperativePain UterusPain, AcuteOpioid UseAnalgesics, Antipyretics, and Antirheumatics Causing Adverse Effects in Therapeutic UseVisceral Pain
Interventions
DRUG

Tapentadol

"* Palexia depot 50 mg® (tapentadol depot 50 mg): Administered by the patient as oral premedication 1 hour before scheduled start of surgery. Palexia depot is repeated once after 12 hours.~* Palexia 50 mg® (tapentadol 50 mg): Administered as oral rescue medicine. First possible administration in postoperative ward when the patient is awake and available for oral medication. Maximum 4 tablets/24-hour study period. Minimum 1 hour 15 minutes between tablets. The patient is instructed to take 1 tablet if pain is increasing and the minimum period since last tablet is exceeded."

DRUG

Oxycodone

"* OxyContin 10 mg® (oxycodone extended-release 10 mg): Administered by the patient as oral premedication 1 hour before scheduled start of surgery. OxyContin is repeated once after 12 hours.~* OxyNorm 10 mg® (oxycodone immediate-release 10 mg): Administered as oral rescue medicine. First possible administration in postoperative ward when the patient is awake and available for oral medication. Maximum 4 capsules/24-hour study period. Minimum 1 hour 15 minutes between capsules. The patient is instructed to take 1 tablet if pain is increasing and the minimum period since last tablet is exceeded."

Trial Locations (1)

0424

Oslo University Hospital, Oslo

All Listed Sponsors
lead

Oslo University Hospital

OTHER

NCT03314792 - Effects of Tapentadol Versus Oxycodone After Hysterectomy. | Biotech Hunter | Biotech Hunter