Postoperative PainPhase 4OOEOPAOANCT02296333
Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen
A Phase 4 study testing ondansetron and isotonic in people with Postoperative Pain, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to determine whether the effect of ondansetron on the analgesic effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen and also reduce opioid consumption Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ondansetron and isotonic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to Dec 2014
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-80 years old scheduled for hysterectomy
- Horizontal or vertical abdominal skin incision
- Ability to operate a patient-controlled analgesia (PCA) device
- Written informed consent.
Who cannot join
- Emergency or urgent procedures
- Women with pre-existing chronic pain at any site requiring opioid analgesia
- Who had a history of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- Significant hepatic (alanine aminotransferase or aspartate aminotransferase >2 times normal) or renal (serum creatinine >2 mg/dl) impairment
- Allergy to ondansetron or acetaminophen
- Were pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Kemal University Medicine Faculty
Hatay, 31030
About this study
Official title: Double Blinded Study Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen
The purpose of the study is to determine whether the effect of ondansetron on the analgesic effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen and also reduce opioid consumption
Read the detailed description
The investigators enrolled 80 American Society of Anesthesiologists Physical Status I-II women 18-80 years old scheduled for hysterectomy under general anesthesia over the course of a year. The study will be restricted hysterectomies with horizontal abdominal skin incision who will be able to operate a patient-controlled analgesia (PCA) device.
Participating women will be premedicated with 1-2 mg intravenous (IV) midazolam per preference of the attending anesthesiologist.
Anesthesia will be induced with propofol (2 mg/kg IV); intubation will be facilitated by rocuronium (0.6 mg/kg IV); and anesthesia will be maintained by sevoflurane in combination with nitrous oxide 50% in oxygen. Fentanyl, 2 µg/kg intravenous will be given 3-5 min before the surgical incision.
After endotracheal intubation, all patients' lungs will be mechanically ventilated to maintain the end-expiratory carbon dioxide values between 34 and 36 mmHg.
A Pfannenstiel approach will be used in each woman, and the same surgeon will be conducted all operations.
Randomization will be web-based and out of the control of any investigator. The web system will be accessed by the anesthesia resident at the induction. Drugs will be covered by opaque plastic to keep the surgical team and anesthesiologists blinded to treatment.
Both groups patients will be received 1 g acetaminophen in 100 ml saline given every 6 hours starting with the skin closure for 24 hours, an amount generally regarded as safe.
- Group I patients will be received '8 mg ondansetron hydrochloride'
- Group II patients will be received '2 ml saline' Both of them will be applied in a 100 ml saline bag at the same time with the skin closure.
After return of spontaneous ventilation and tracheal extubation, patients will be transferred to the post anesthesia care unit (PACU).
Patients were connected to a patient-controlled analgesia (PCA) device and postoperative analgesia will be provided using 20-mg intravenous bolus injections of tramadol at a lockout interval of 15 min and with a maximum 4-h limit of 150 mg. The PCA device will be discontinued when the patient made no demands for the opioid analgesic in the preceding 4-h interval or at a maximum of 24 hours after surgery.
- heart rate
- systolic arterial blood pressures
- diastolic arterial blood pressures
- mean arterial blood pressures
- oxygen saturation
- respiratory rate
- visual analogue scales while sitting and laying
- tramadol consumption
- additive analgesics
- complications
- postoperative nausea and vomiting scores
- antiemetic use will be assessed at PACU, 1th. hour, 4th hour, 8th hour, 12th hour, 16th hour, 20th hour and 24th hour.
- Pain satisfaction scale
- ambulation time
- first flatus time
- oral intake time
- Hospital anxiety and depression scale
When pain scores were VAS ≥5, then as a rescue analgesics 75 mg diclofenac Na intramuscularly will be given. If systolic arterial pressure (SAP) will be <90 mmHg or mean arterial pressure will be <50 mmHg, 5 mg intravenous ephedrine HCl will be given. If the heart rate will be <50 beats/minute, 0.5 mg atropine sulfate intravenous will be given. When patients sustained nausea or vomiting lasting longer than 5 minutes, metoclopramide (10 mg intravenously) will be given.
- Conditions
- Postoperative Pain
- Being tested
- ondansetron, isotonic
- Keywords
- Acetaminophen, ondansetron
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetronDrug
Also called Zofran
8 mg intravenous in the skin closure
isotonicDrug
8 mg intravenous in the skin closure
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Active comparator | ondansetron iv, 8 mg, skin closure time Receives: Drug: ondansetron |
| isotonic | Placebo comparator | isotonic 2ml, once, skin closure time Receives: Drug: isotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Visual analogue scale
Measured: Postoperative 24 hours
Opioid (tramadol) consumption
Tramadol consumption
Measured: Postoperative 24 hours
Secondary outcomes (1)
Postoperative complications
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koyuncu, Mustafa Kemal University
- Investigators
- Onur Koyuncu, Ass.prof, Study chair, Mustafa Kemal University Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296333
- Sponsor's protocol ID
- 03 2014 05
- Acronym
- OOEOPAOA
- Status last verified
- Mar 2015
- First submitted
- 24 Aug 2014
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tjolsen A, Lund A, Hole K. Antinociceptive effect of paracetamol in rats is partly dependent on spinal serotonergic systems. Eur J Pharmacol. 1991 Feb 7;193(2):193-201. doi: 10.1016/0014-2999(91)90036-p.
PubMed 1904822Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
PubMed 16580905Jokela R, Ahonen J, Seitsonen E, Marjakangas P, Korttila K. The influence of ondansetron on the analgesic effect of acetaminophen after laparoscopic hysterectomy. Clin Pharmacol Ther. 2010 Jun;87(6):672-8. doi: 10.1038/clpt.2009.281. Epub 2010 Mar 10.
PubMed 20220746
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Study Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen
- ClinicalTrials.gov ID
- NCT02296333
- Acronym / sponsor ID
- OOEOPAOA / 03 2014 05
- Conditions
- Postoperative Pain
- Keywords
- Acetaminophen, ondansetron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2014 (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.
The purpose of the study is to determine whether the effect of ondansetron on the analgesic effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen and also reduce opioid consumption
Detailed description
The investigators enrolled 80 American Society of Anesthesiologists Physical Status I-II women 18-80 years old scheduled for hysterectomy under general anesthesia over the course of a year. The study will be restricted hysterectomies with horizontal abdominal skin incision who will be able to operate a patient-controlled analgesia (PCA) device.
Participating women will be premedicated with 1-2 mg intravenous (IV) midazolam per preference of the attending anesthesiologist.
Anesthesia will be induced with propofol (2 mg/kg IV); intubation will be facilitated by rocuronium (0.6 mg/kg IV); and anesthesia will be maintained by sevoflurane in combination with nitrous oxide 50% in oxygen. Fentanyl, 2 µg/kg intravenous will be given 3-5 min before the surgical incision.
After endotracheal intubation, all patients' lungs will be mechanically ventilated to maintain the end-expiratory carbon dioxide values between 34 and 36 mmHg.
A Pfannenstiel approach will be used in each woman, and the same surgeon will be conducted all operations.
Randomization will be web-based and out of the control of any investigator. The web system will be accessed by the anesthesia resident at the induction. Drugs will be covered by opaque plastic to keep the surgical team and anesthesiologists blinded to treatment.
Both groups patients will be received 1 g acetaminophen in 100 ml saline given every 6 hours starting with the skin closure for 24 hours, an amount generally regarded as safe.
- Group I patients will be received '8 mg ondansetron hydrochloride'
- Group II patients will be received '2 ml saline' Both of them will be applied in a 100 ml saline bag at the same time with the skin closure.
After return of spontaneous ventilation and tracheal extubation, patients will be transferred to the post anesthesia care unit (PACU).
Patients were connected to a patient-controlled analgesia (PCA) device and postoperative analgesia will be provided using 20-mg intravenous bolus injections of tramadol at a lockout interval of 15 min and with a maximum 4-h limit of 150 mg. The PCA device will be discontinued when the patient made no demands for the opioid analgesic in the preceding 4-h interval or at a maximum of 24 hours after surgery.
- heart rate
- systolic arterial blood pressures
- diastolic arterial blood pressures
- mean arterial blood pressures
- oxygen saturation
- respiratory rate
- visual analogue scales while sitting and laying
- tramadol consumption
- additive analgesics
- complications
- postoperative nausea and vomiting scores
- antiemetic use will be assessed at PACU, 1th. hour, 4th hour, 8th hour, 12th hour, 16th hour, 20th hour and 24th hour.
- Pain satisfaction scale
- ambulation time
- first flatus time
- oral intake time
- Hospital anxiety and depression scale
When pain scores were VAS ≥5, then as a rescue analgesics 75 mg diclofenac Na intramuscularly will be given. If systolic arterial pressure (SAP) will be <90 mmHg or mean arterial pressure will be <50 mmHg, 5 mg intravenous ephedrine HCl will be given. If the heart rate will be <50 beats/minute, 0.5 mg atropine sulfate intravenous will be given. When patients sustained nausea or vomiting lasting longer than 5 minutes, metoclopramide (10 mg intravenously) will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Active comparator | Drug: ondansetronondansetron iv, 8 mg, skin closure time |
| isotonic | Placebo comparator | Drug: isotonicisotonic 2ml, once, skin closure time |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18-80 years old scheduled for hysterectomy
- Horizontal or vertical abdominal skin incision
- Ability to operate a patient-controlled analgesia (PCA) device
- Written informed consent.
Key exclusion criteria (6 listed)
- Emergency or urgent procedures
- Women with pre-existing chronic pain at any site requiring opioid analgesia
- Who had a history of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- Significant hepatic (alanine aminotransferase or aspartate aminotransferase >2 times normal) or renal (serum creatinine >2 mg/dl) impairment
- Allergy to ondansetron or acetaminophen
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 |
|---|---|---|
| ondansetronAlso: Zofran8 mg intravenous in the skin closure | Drug | ondansetron |
| isotonic8 mg intravenous in the skin closure | Drug | isotonic |
Primary outcome
Postoperative pain
Time frame: Postoperative 24 hours
Visual analogue scale
Opioid (tramadol) consumption
Time frame: Postoperative 24 hours
Tramadol consumption
1 secondary outcome
Postoperative complications
Time frame: Postoperative 24 hours
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 13 Mar 2015.
- Results publication: PubMed 1904822Tjolsen A, Lund A, Hole K. Antinociceptive effect of paracetamol in rats is partly dependent on spinal serotonergic systems. Eur J Pharmacol. 1991 Feb 7;193(2):193-201. doi: 10.1016/0014-2999(91)90036-p.
- Results publication: PubMed 16580905Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
- Results publication: PubMed 20220746Jokela R, Ahonen J, Seitsonen E, Marjakangas P, Korttila K. The influence of ondansetron on the analgesic effect of acetaminophen after laparoscopic hysterectomy. Clin Pharmacol Ther. 2010 Jun;87(6):672-8. doi: 10.1038/clpt.2009.281. Epub 2010 Mar 10.
- http://www.ncbi.nlm.nih.gov/pubmed/20220746Link provided by the sponsor.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Onur Koyuncu, Ass.prof study chair
Mustafa Kemal University Medicine Faculty
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 ondansetron and isotonic in people with Postoperative Pain, run by Mustafa Kemal 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 4 inclusion and 6 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 13 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Postoperative pain (time frame: Postoperative 24 hours). 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?
On the ClinicalTrials.gov record for NCT02296333, which also lists 3 linked publications.
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 13 Mar 2015.