Postoperative Nausea and VomitingPhase 4NCT03588338
Paracetamol on Postoperative Nausea and Vomiting
A Phase 4 study testing Perfalgan in people with Postoperative Nausea and Vomiting, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Perfalgan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2018to 21 Aug 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA (the classification of the American Society of Anesthesiologists) physical status I-II
- Patients who scheduled for elective maxillofacial surgery under general anesthesia
Who cannot join
- Patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol)
- History of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases
- Use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery.
Read the detailed description
One hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Perfalgan, Control
- Keywords
- PONV, Paracetamol
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerfalganDrug
Also called Paracetamol
For postoperative pain
ControlDrug
Also called Saline
For postoperative nausea and vomiting
| Study group | Role | What they receive |
|---|---|---|
| Perfalgan | Active comparator | 1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery) Receives: Drug: Perfalgan; Drug: Control |
| Control | Other | 1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery) Receives: Drug: Perfalgan; Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventing of postoperative nausea and vomiting
Preventing of postoperative nausea and vomiting in postoperative care unit
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start20 Jul 2018
- Primary completion20 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Kocaturk, Aydin Adnan Menderes University
- Investigators
- Adnan Menderes University, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588338
- Sponsor's protocol ID
- 2017/1081
- Status last verified
- Aug 2020
- First submitted
- 5 Jul 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cok OY, Eker HE, Pelit A, Canturk S, Akin S, Aribogan A, Arslan G. The effect of paracetamol on postoperative nausea and vomiting during the first 24 h after strabismus surgery: a prospective, randomised, double-blind study. Eur J Anaesthesiol. 2011 Dec;28(12):836-41. doi: 10.1097/EJA.0b013e32834c580b.
PubMed 21986980
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
- ClinicalTrials.gov ID
- NCT03588338
- Acronym / sponsor ID
- 2017/1081
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, Paracetamol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 17 Jul 2018 (actual)
- 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.
The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery.
Detailed description
One hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfalgan | Active comparator | Drug: Perfalgan, Drug: Control1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery) |
| Control | Other | Drug: Perfalgan, Drug: Control1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA (the classification of the American Society of Anesthesiologists) physical status I-II
- Patients who scheduled for elective maxillofacial surgery under general anesthesia
Key exclusion criteria (3 listed)
- Patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol)
- History of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases
- Use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery
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 |
|---|---|---|
| PerfalganAlso: ParacetamolFor postoperative pain | Drug | Control, Perfalgan |
| ControlAlso: SalineFor postoperative nausea and vomiting | Drug | Control, Perfalgan |
Primary outcome
Preventing of postoperative nausea and vomiting
Time frame: First 24 hours postoperatively
Preventing of postoperative nausea and vomiting in postoperative care unit
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 12 Aug 2020.
- Background: PubMed 21986980Cok OY, Eker HE, Pelit A, Canturk S, Akin S, Aribogan A, Arslan G. The effect of paracetamol on postoperative nausea and vomiting during the first 24 h after strabismus surgery: a prospective, randomised, double-blind study. Eur J Anaesthesiol. 2011 Dec;28(12):836-41. doi: 10.1097/EJA.0b013e32834c580b.
- Individual participant dataSharing planned: No
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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.
Adnan Menderes University study director
Aydin Adnan Menderes University
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 Perfalgan in people with Postoperative Nausea and Vomiting, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 3 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 12 Aug 2020. 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 Turkey (Türkiye). 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?
Preventing of postoperative nausea and vomiting (time frame: First 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03588338, which also lists 1 linked publication.
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 12 Aug 2020.