a Single-Dose of EtoricoxibPhase 3NCT00149253
Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain
A Phase 3 study testing a single-dose of Etoricoxib before induction of anesthesia in people with a Single-Dose of Etoricoxib and Post-Operative Morphine Consumption, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Taken together, studies of the value of pre-emptive analgesia are inconclusive. This randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- a Single-Dose of Etoricoxib, Post-Operative Morphine Consumption, Total Pain Relief Over 8 Hr(TOPAR8)
- What is being tested?
- a single-dose of Etoricoxib before induction of anesthesia
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2004to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The ASA I or II patients undergoing elective transabdominal hysterectomy with general anesthesia
Who cannot join
- Patients with history of opioid addiction or chronic pain
- Allergy to other nonsteroidal anti-inflammatory, or asthma
- Concomitant use of tricyclic antidepressants, opioid analgesics, antihistamines, tranquilizers, hypnotics, sedatives, or systemic corticosteroids
- Those unable to understand the principle of patient-controlled analgesia(PCA) device were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy
Taken together, studies of the value of pre-emptive analgesia are inconclusive. This randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia.
Read the detailed description
Patients undergoing transabdominal hysterectomy were randomized to a group taking a single dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2 hours before surgery under the same standardized general anesthesia. At the post-anesthetic care unit, intravenous morphine titration was given before starting self-controlled analgesia (PCA) device. Morphine consumption, pain relief score, sedative score, global evaluation score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. The primary end points were morphine consumption within 24-hr post-operatively and total pain relief over 8 h (TOPAR8). Patient global satisfaction was also assessed.
- Conditions
- a Single-Dose of Etoricoxib, Post-Operative Morphine Consumption, Total Pain Relief Over 8 Hr(TOPAR8), Post Transabdominal Hysterectomy
- Being tested
- a single-dose of Etoricoxib before induction of anesthesia
- Keywords
- Abdominal hysterectomy,, Etoricoxib,, morphine consumption,, pre-emptive analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a single-dose of Etoricoxib before induction of anesthesiaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end points were morphine consumption within 24-hr post-operatively
and total pain relief over 8 h (TOPAR8).
Secondary outcomes (1)
Patient global response to therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startDec 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for a Single-Dose of EtoricoxibStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- waraporn chau-in, Asso Prof., Principal investigator, Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149253
- Sponsor's protocol ID
- acute pain service
- Other IDs
- Faculty of Medicine,KhonKaenU
- Status last verified
- Oct 2004
- First submitted
- 6 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00149253
- Acronym / sponsor ID
- acute pain service
- Conditions
- a Single-Dose of Etoricoxib, Post-Operative Morphine Consumption, Total Pain Relief Over 8 Hr(TOPAR8), Post Transabdominal Hysterectomy
- Keywords
- Abdominal hysterectomy,, Etoricoxib,, morphine consumption,, pre-emptive analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- May 2005
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taken together, studies of the value of pre-emptive analgesia are inconclusive. This randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia.
Detailed description
Patients undergoing transabdominal hysterectomy were randomized to a group taking a single dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2 hours before surgery under the same standardized general anesthesia. At the post-anesthetic care unit, intravenous morphine titration was given before starting self-controlled analgesia (PCA) device. Morphine consumption, pain relief score, sedative score, global evaluation score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. The primary end points were morphine consumption within 24-hr post-operatively and total pain relief over 8 h (TOPAR8). Patient global satisfaction was also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The ASA I or II patients undergoing elective transabdominal hysterectomy with general anesthesia
Key exclusion criteria (4 listed)
- Patients with history of opioid addiction or chronic pain
- Allergy to other nonsteroidal anti-inflammatory, or asthma
- Concomitant use of tricyclic antidepressants, opioid analgesics, antihistamines, tranquilizers, hypnotics, sedatives, or systemic corticosteroids
- Those unable to understand the principle of patient-controlled analgesia(PCA) device were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a single-dose of Etoricoxib before induction of anesthesia | Drug | – |
Primary outcome
The primary end points were morphine consumption within 24-hr post-operatively
and total pain relief over 8 h (TOPAR8).
1 secondary outcome
Patient global response to therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2005.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
waraporn chau-in, Asso Prof. principal investigator
Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing a single-dose of Etoricoxib before induction of anesthesia in people with a Single-Dose of Etoricoxib and Post-Operative Morphine Consumption, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end points were morphine consumption within 24-hr post-operatively. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2005.