NCT01947205

Brief Summary

Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

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

November 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

September 16, 2013

Last Update Submit

September 19, 2013

Conditions

CurettageAnalgesiaParacervical BlockParacetamol

Keywords

Curettageanalgesiaparacervical blockparacetamollidocaineDexketoprofen trometamol

Outcome Measures

Primary Outcomes (1)

  • pain reduction

    nine months

Study Arms (5)

paracetamol

ACTIVE COMPARATOR

Duration

Drug: paracetamol

without drug

ACTIVE COMPARATOR

Control group

Other: without drug

dexketoprofen trometamol

ACTIVE COMPARATOR

Study group

Drug: dexketoprofen trometamol

two puff xylocain administration on cervical surface

ACTIVE COMPARATOR

Study group

Drug: suction curettage

paracervical block with ultracaine

ACTIVE COMPARATOR

study group

Drug: suction curettage

Interventions

paracetamolDRUG
paracetamol
dexketoprofen trometamolDRUG
dexketoprofen trometamol
suction curettageDRUG
Also known as: two puff xylocain administration
two puff xylocain administration on cervical surface
without drugOTHER
without drug

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.

You may not qualify if:

  • incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets… etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Education and Research Hospital of Medicine

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (1)

  • Acmaz G, Aksoy H, Ozoglu N, Aksoy U, Albayrak E. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, and paracervical block application for pain relief during suction termination of first-trimester pregnancy. Biomed Res Int. 2013;2013:869275. doi: 10.1155/2013/869275. Epub 2013 Dec 24.

    PMID: 24455735DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophendexketoprofen trometamolVacuum CurettageAnesthesia, ObstetricalCarticainePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDilatation and CurettageCurettageSurgical Procedures, OperativeGynecologic Surgical ProceduresUrogenital Surgical ProceduresAnesthesiaAnesthesia and AnalgesiaThiophenesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gökhan Açmaz, MD

    Kayseri Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Kayseri Education and Research Hospital

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 20, 2013

Study Start

November 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

TU(1)