NCT02296333

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

August 24, 2014

Last Update Submit

March 12, 2015

Conditions

Postoperative Pain

Keywords

Acetaminophen, ondansetron

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    Visual analogue scale

    Postoperative 24 hours

  • Opioid (tramadol) consumption

    Tramadol consumption

    Postoperative 24 hours

Secondary Outcomes (1)

  • Postoperative complications

    Postoperative 24 hours

Study Arms (2)

ondansetron

ACTIVE COMPARATOR

ondansetron iv, 8 mg, skin closure time

Drug: ondansetron

isotonic

PLACEBO COMPARATOR

isotonic 2ml, once, skin closure time

Drug: isotonic

Interventions

ondansetronDRUG

8 mg intravenous in the skin closure

Also known as: Zofran
ondansetron
isotonicDRUG

8 mg intravenous in the skin closure

isotonic

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University Medicine Faculty

Hatay, 31030, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 1904822RESULT

  • 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.

    PMID: 16580905RESULT

  • 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.

    PMID: 20220746RESULT

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Onur Koyuncu, Ass.prof

    Mustafa Kemal University Medicine Faculty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

August 24, 2014

First Posted

November 20, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

TU(1)