Other Acute Postoperative PainPhase 2NCT01858402
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
A Phase 2 study testing Paracetamol and Dipyrone in people with Other Acute Postoperative Pain, run by Baskent University.
Trial summary
We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Acute Postoperative Pain
- What is being tested?
- Paracetamol and Dipyrone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jul 2011
- Phase
- Phase 2
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery
Who cannot join
- increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs
About this study
Official title: The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study
We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.
Read the detailed description
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.
- Conditions
- Other Acute Postoperative Pain
- Being tested
- Paracetamol, Dipyrone
- Keywords
- Pediatric spinal anesthesia, paracetamol, dipyrone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Parol
15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
DipyroneDrug
Also called Metamizole
15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | 15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose Receives: Drug: Paracetamol |
| Dipyrone | Active comparator | 15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose Receives: Drug: Dipyrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pain intensity until postoperative 6 hours
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.
Measured: Pain intensity recorded until postoperative 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Acute Postoperative 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Caliskan, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858402
- Sponsor's protocol ID
- KA 09/06
- Status last verified
- May 2013
- First submitted
- 16 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caliskan E, Sener M, Kocum A, Ozyilkan NB, Ezer SS, Aribogan A. The efficacy of intravenous paracetamol versus dipyrone for postoperative analgesia after day-case lower abdominal surgery in children with spinal anesthesia: a prospective randomized double-blind placebo-controlled study. BMC Anesthesiol. 2013 Oct 22;13(1):34. doi: 10.1186/1471-2253-13-34.
PubMed 24144215
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT01858402
- Acronym / sponsor ID
- KA 09/06
- Conditions
- Other Acute Postoperative Pain
- Keywords
- Pediatric spinal anesthesia, paracetamol, dipyrone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 May 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.
We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.
Detailed description
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: Paracetamol15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose |
| Dipyrone | Active comparator | Drug: Dipyrone15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery
Key exclusion criteria (1 listed)
- increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs
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: Parol15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose | Drug | Paracetamol |
| DipyroneAlso: Metamizole15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose | Drug | Dipyrone |
Primary outcome
Change from pain intensity until postoperative 6 hours
Time frame: Pain intensity recorded until postoperative 6 hours
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.
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 21 May 2013.
- Derived from this study: PubMed 24144215Caliskan E, Sener M, Kocum A, Ozyilkan NB, Ezer SS, Aribogan A. The efficacy of intravenous paracetamol versus dipyrone for postoperative analgesia after day-case lower abdominal surgery in children with spinal anesthesia: a prospective randomized double-blind placebo-controlled study. BMC Anesthesiol. 2013 Oct 22;13(1):34. doi: 10.1186/1471-2253-13-34.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paracetamol and Dipyrone in people with Other Acute Postoperative Pain, run by Baskent University.
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 1 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 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from pain intensity until postoperative 6 hours (time frame: Pain intensity recorded until postoperative 6 hours). 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 NCT01858402, which also lists 1 linked publication.
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 21 May 2013.