Laparoscopic CholecystectomyPhase 4NCT00292214
Comparing Intravenous and Oral Paracetamol for Cholecystectomy
A Phase 4 study testing Paracetamol (acetaminophen) in people with Laparoscopic Cholecystectomy, run by Melbourne Health at 1 site in Australia.
Trial summary
To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Paracetamol (acetaminophen)
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2005to Oct 2006
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-75
- Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia
Who cannot join
- Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
- History of allergy or sensitivity to paracetamol
- Administration of oral paracetamol within previous 8 hours
- American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
- Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Paracetamol (acetaminophen)
- Keywords
- paracetamol, acetaminophen, pharmacokinetic, intravenous, oral, analgesia, pain, opioid
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol (acetaminophen)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Secondary outcomes (1)
Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startOct 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Investigators
- Malcolm Hogg, Anaesthetist, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292214
- Sponsor's protocol ID
- 2005.138
- Status last verified
- Feb 2006
- First submitted
- 13 Feb 2006
- Last updated
- 9 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00292214
- Acronym / sponsor ID
- 2005.138
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- paracetamol, acetaminophen, pharmacokinetic, intravenous, oral, analgesia, pain, opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Oct 2006
- First posted
- 15 Feb 2006 (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.
To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females aged 18-75
- Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia
Key exclusion criteria (5 listed)
- Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
- History of allergy or sensitivity to paracetamol
- Administration of oral paracetamol within previous 8 hours
- American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
- Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)
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 |
|---|---|---|
| Paracetamol (acetaminophen) | Drug | – |
Primary outcome
Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
1 secondary outcome
Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
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 9 Mar 2007.
Related trials for Laparoscopic Cholecystectomy
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
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.
Malcolm Hogg, Anaesthetist principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol (acetaminophen) in people with Laparoscopic Cholecystectomy, run by Melbourne Health at 1 site in Australia.
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 2 inclusion and 5 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 9 Mar 2007. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations. 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 9 Mar 2007.