Abdominal PainPhase 3NCT02465255
Sublingual Analgesia for Acute Abdominal Pain in Children
A Phase 3 study testing Ketorolac, Tramadol and Acetaminophen in people with Abdominal Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Acute abdominal pain is a frequent symptom in children admitted to the emergency department . In the past the fear of masking a surgical condition has justified withholding analgesia in patients with acute abdominal pain. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Ketorolac, Tramadol and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Jun 2017
- Phase
- Phase 3
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 4 to 18 years
- Emergency department admission for moderate to severe acute abdominal pain (VAS/NRS score >=6)
- Informed consent signed by parents or legal guardians
Who cannot join
- Known allergy or sensitivity to nonsteroidal anti-inflammatory drug, opioids or acetaminophen
- Use of analgesic drugs in the 8 hours before
- Clinical suspicion of abdominal pain due to fecal stasis
- Moderate or severe dehydration (weight loss of more than 5%)
- Known nephropathy, liver disease, metabolic or neurologic disease
- Thrombocytopenia or history of bleeding disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial
Acute abdominal pain is a frequent symptom in children admitted to the emergency department . In the past the fear of masking a surgical condition has justified withholding analgesia in patients with acute abdominal pain. By the 2000s, some clinical trials established that opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome in children with acute abdominal pain. Despite this, acute abdominal pain is still undertreated in this setting. Published paediatric trials studied the effect of opioid analgesia administered by parenteral route or by mouth. To the best of our knowledge no study investigated the effectiveness of sublingual analgesia.
The purpose of this randomized controlled trial is to assess the effectiveness of three different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in children complaining of acute abdominal pain.
- Conditions
- Abdominal Pain
- Being tested
- Ketorolac, Tramadol, Acetaminophen
- Keywords
- Acute Abdominal Pain, Sublingual Analgesia, Children, Ketorolac, Tramadol, Paracetamol, Analgesia
- Medical subject headings
- Abdominal Pain, Abdomen, Acute, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
TramadolDrug
AcetaminophenDrug
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | Ketorolac 0.5 mg/kg administrated by sublingual route Receives: Drug: Ketorolac |
| Tramadol | Active comparator | Tramadol 2.0 mg/kg administrated by sublingual route Receives: Drug: Tramadol |
| Acetaminophen (paracetamol) | Active comparator | Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Measured: 120 minutes after drug administration
Secondary outcomes (5)
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Measured: 30 minutes after drug administration
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Measured: 60 minutes after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Measured: 24 hours after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Measured: 48 hours after drug administration
Adverse events
Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding
Measured: up to 180 hours after the drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ronfani, IRCCS Burlo Garofolo
- Investigators
- Egidio Barbi, MD, Study chair, IRCCS Burlo Garofolo, Trieste, ItalyElena Neri, MD, Study director, IRCCS Burlo Garofolo, Trieste, ItalyGiorgio Cozzi, MD, Principal investigator, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465255
- Sponsor's protocol ID
- RC 22/13
- Status last verified
- Aug 2017
- First submitted
- 3 Jun 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial
- ClinicalTrials.gov ID
- NCT02465255
- Acronym / sponsor ID
- RC 22/13
- Conditions
- Abdominal Pain
- Keywords
- Acute Abdominal Pain, Sublingual Analgesia, Children, Ketorolac, Tramadol, Paracetamol, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Jun 2015 (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.
Acute abdominal pain is a frequent symptom in children admitted to the emergency department . In the past the fear of masking a surgical condition has justified withholding analgesia in patients with acute abdominal pain. By the 2000s, some clinical trials established that opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome in children with acute abdominal pain. Despite this, acute abdominal pain is still undertreated in this setting. Published paediatric trials studied the effect of opioid analgesia administered by parenteral route or by mouth. To the best of our knowledge no study investigated the effectiveness of sublingual analgesia.
The purpose of this randomized controlled trial is to assess the effectiveness of three different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in children complaining of acute abdominal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: KetorolacKetorolac 0.5 mg/kg administrated by sublingual route |
| Tramadol | Active comparator | Drug: TramadolTramadol 2.0 mg/kg administrated by sublingual route |
| Acetaminophen (paracetamol) | Active comparator | Drug: AcetaminophenAcetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 4 to 18 years
- Emergency department admission for moderate to severe acute abdominal pain (VAS/NRS score >=6)
- Informed consent signed by parents or legal guardians
Key exclusion criteria (6 listed)
- Known allergy or sensitivity to nonsteroidal anti-inflammatory drug, opioids or acetaminophen
- Use of analgesic drugs in the 8 hours before
- Clinical suspicion of abdominal pain due to fecal stasis
- Moderate or severe dehydration (weight loss of more than 5%)
- Known nephropathy, liver disease, metabolic or neurologic disease
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 |
|---|---|---|
| Ketorolac | Drug | Ketorolac |
| Tramadol | Drug | Tramadol |
| Acetaminophen | Drug | Acetaminophen (paracetamol) |
Primary outcome
Pain Score
Time frame: 120 minutes after drug administration
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
5 secondary outcomes
Pain Score
Time frame: 30 minutes after drug administration
Pain Score
Time frame: 60 minutes after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Time frame: 24 hours after drug administration
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Time frame: 48 hours after drug administration
Adverse events
Time frame: up to 180 hours after the drug administration
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 22 Aug 2017.
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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.
Egidio Barbi, MD study chair
IRCCS Burlo Garofolo, Trieste, Italy
Elena Neri, MD study director
IRCCS Burlo Garofolo, Trieste, Italy
Giorgio Cozzi, MD principal investigator
IRCCS Burlo Garofolo, Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac, Tramadol and Acetaminophen in people with Abdominal Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 3 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 22 Aug 2017. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain Score (time frame: 120 minutes after drug administration). 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 22 Aug 2017.