Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery

NCT00735748 | Completed Phase 4

• 1 other identifier: 2007/526
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.

Conditions

Pain

Keywords

Patients who will undergo a general anesthesia for a procedure in short stay

Outcome Measures

Primary Outcomes (1)

• Difference in pain score between groups

  In the first hours after anaesthesia and surgery

Secondary Outcomes (1)

• Difference in side-effects between the groups

  In the first hours after anaesthesia and surgery

Study Arms (2)

1

EXPERIMENTAL

Tramadol per os (Tradonal Odis® orodispersible tablets)

Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)

2

ACTIVE COMPARATOR

Tramadol IV (Tradonal® IV)

Drug: Tramadol IV (Tradonal® IV)

Interventions

Tramadol per os (Tradonal Odis® orodispersible tablets) DRUG

Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages

1

Tramadol IV (Tradonal® IV) DRUG

Administration of tramadol IV given in 3 unit dosage of 35 mg

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I and II female or male patients undergoing wisdom teeth extraction
• Aged 18-70 years
• Scheduled for ambulatory surgery requiring postoperative pain medication

You may not qualify if:

• Weight less than 70% or more than 130% of ideal body weight
• Neurological disorder
• Recent use of psycho-active medication, including alcohol
• Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
• Use of chronic anti-emetic medication
• Use of chronic corticoid therapy

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Struys, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: March 1, 2008
• Primary Completion: June 19, 2009
• Study Completion: June 19, 2009
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

BE (1)