Labor PainPhase 4NCT01394731
Analgesic Effects of Intravenous Paracetamol on Labor Pain
A Phase 4 study testing Acetaminophen and Meperidine in people with Labor Pain, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Acetaminophen and Meperidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2010to Jul 2011
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical class I-II
- term patients (≥ 37 weeks of gestation)
Who cannot join
- previous cesarean section
- hypertension, pre-eclampsia, eclampsia
- intra-uterine growth retardation
- intrauterine fetal death
- morbid obesity (body mass index ≥ 35)
- allergy to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effects of Intravenous Acetaminophen on Labor Pain
The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.
- Conditions
- Labor Pain
- Being tested
- Acetaminophen, Meperidine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
MeperidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol 1 | Experimental | Not described Receives: Drug: Acetaminophen |
| Paraceatmol 2 | Experimental | Not described Receives: Drug: Acetaminophen |
| Meperidine | Active comparator | Not described Receives: Drug: Meperidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) score for pain
Patients who give written informed consent to participate will be entered into the study. Their VAS score will be determined every hour from the time of randomization until delivery of the baby. This time will vary from one patient to another depending on the duration of labor.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394731
- Sponsor's protocol ID
- RC08-052
- Status last verified
- Jul 2011
- First submitted
- 12 Jul 2011
- Last updated
- 14 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Intravenous Acetaminophen on Labor Pain
- ClinicalTrials.gov ID
- NCT01394731
- Acronym / sponsor ID
- RC08-052
- Conditions
- Labor Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Collaborators
- King Abdulaziz Medical City
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Jul 2011 (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 this study is to determine whether intravenous paracetamol is effective in treating labor pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracetamol 1 | Experimental | Drug: Acetaminophen |
| Paraceatmol 2 | Experimental | Drug: Acetaminophen |
| Meperidine | Active comparator | Drug: Meperidine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical class I-II
- term patients (≥ 37 weeks of gestation)
Key exclusion criteria (6 listed)
- previous cesarean section
- hypertension, pre-eclampsia, eclampsia
- intra-uterine growth retardation
- intrauterine fetal death
- morbid obesity (body mass index ≥ 35)
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 |
|---|---|---|
| Acetaminophen | Drug | Paraceatmol 2, Paracetamol 1 |
| Meperidine | Drug | Meperidine |
Primary outcome
Visual analogue scale (VAS) score for pain
Time frame: Up to 24 hours
Patients who give written informed consent to participate will be entered into the study. Their VAS score will be determined every hour from the time of randomization until delivery of the baby. This time will vary from one patient to another depending on the duration of labor.
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 14 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acetaminophen and Meperidine in people with Labor Pain, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 2 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 14 Jul 2011. 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 Saudi Arabia. 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.
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?
Visual analogue scale (VAS) score for pain (time frame: Up to 24 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 14 Jul 2011.