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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

  1. Group I patients will be received '8 mg ondansetron hydrochloride'
  2. 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.

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 groups in NCT02296333
Study groupRoleWhat they receive
ondansetronActive comparatorondansetron iv, 8 mg, skin closure time
Receives: Drug: ondansetron
isotonicPlacebo comparatorisotonic 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.

  1. Postoperative pain

    Visual analogue scale

    Measured: Postoperative 24 hours

  2. Opioid (tramadol) consumption

    Tramadol consumption

    Measured: Postoperative 24 hours

Secondary outcomes (1)
  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.

  1. First posted20 Nov 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionNov 2014
  4. Study completionDec 2014

Resources

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)
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 1904822
  • Pickering 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 16580905
  • Jokela 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

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.

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OOEOPAOA Clinical Trial NCT02296333 | AzTrials