PainNCT02025166
Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion
A study testing Paracetamol and lornoxicam in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion. The medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Paracetamol and lornoxicam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective surgical abortion for first trimester pregnancy
Who cannot join
- Chronic pelvic pain
- Fibromyalgia
- Pelvic inflammatory disease
- Chronic renal failure, liver disease, peptic ulcer
- cervical stenosis
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa
Lior Lowenstein, MD, MS, 972502061434, l_lior@rambam.health.gov.il
Susana Mustafa, MD
About this study
To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion.
The medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated.
Read the detailed description
Patients with medical indication for surgical abortion during first trimester will be divided to two groups. The study groups, the surgeons and the nurses will be blinded to one of the treatment arms.
Pain will be evaluated at fixed intervals following the abortion. Comparison in pain levels between the study groups will be analysed.
- Conditions
- Pain
- Being tested
- Paracetamol, lornoxicam
- Keywords
- Pain, abortion, paracetamol, lornoxicam
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Pain relief
Pain treatment with "aniline analgesics" (paracetamol) at the time of the procedure
lornoxicamDrug
Also called Pain relief
Pain treatment with "NSAID" (lornoxicam) at the time of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Pain treatment, aniline analgesics Receives: Drug: Paracetamol; Drug: lornoxicam |
| lornoxicam | Active comparator | Pain treatment, nonsteroidal anti-inflammatory (NSAID) Receives: Drug: Paracetamol; Drug: lornoxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain level will be evaluated by VAS
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lior Lowenstein, Rambam Health Care Campus
- Investigators
- Susana Mustafa, MD, Principal investigator, Rambam Health Care CampusNibal Awad, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025166
- Sponsor's protocol ID
- RMB343-13
- Other IDs
- RMB0343-13
- Status last verified
- Dec 2013
- First submitted
- 23 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion
- ClinicalTrials.gov ID
- NCT02025166
- Acronym / sponsor ID
- RMB343-13
- Conditions
- Pain
- Keywords
- Pain, abortion, paracetamol, lornoxicam
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 31 Dec 2013 (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.
To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion.
The medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated.
Detailed description
Patients with medical indication for surgical abortion during first trimester will be divided to two groups. The study groups, the surgeons and the nurses will be blinded to one of the treatment arms.
Pain will be evaluated at fixed intervals following the abortion. Comparison in pain levels between the study groups will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: Paracetamol, Drug: lornoxicamPain treatment, aniline analgesics |
| lornoxicam | Active comparator | Drug: Paracetamol, Drug: lornoxicamPain treatment, nonsteroidal anti-inflammatory (NSAID) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective surgical abortion for first trimester pregnancy
Key exclusion criteria (5 listed)
- Chronic pelvic pain
- Fibromyalgia
- Pelvic inflammatory disease
- Chronic renal failure, liver disease, peptic ulcer
- cervical stenosis
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 |
|---|---|---|
| ParacetamolAlso: Pain reliefPain treatment with "aniline analgesics" (paracetamol) at the time of the procedure | Drug | Paracetamol, lornoxicam |
| lornoxicamAlso: Pain reliefPain treatment with "NSAID" (lornoxicam) at the time of the procedure | Drug | Paracetamol, lornoxicam |
Primary outcome
Pain
Time frame: Two hours
Pain level will be evaluated by VAS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
Related trials for Pain
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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.
Susana Mustafa, MD principal investigator
Rambam Health Care Campus
Nibal Awad, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol and lornoxicam in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Dec 2013. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Lowenstein, MD, MS (97248542653, l_lior@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.