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Sublingual Analgesia for Acute Abdominal Pain in Children

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ketorolac
Tramadol
Acetaminophen
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain focused on measuring Acute Abdominal Pain, Sublingual Analgesia, Children, Ketorolac, Tramadol, Paracetamol, Analgesia

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • IRCCS Burlo Garofolo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Ketorolac

Tramadol

Acetaminophen (paracetamol)

Arm Description

Ketorolac 0.5 mg/kg administrated by sublingual route

Tramadol 2.0 mg/kg administrated by sublingual route

Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route

Outcomes

Primary Outcome Measures

Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age

Secondary Outcome Measures

Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Pain Score
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Adverse events
Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding

Full Information

First Posted
June 3, 2015
Last Updated
August 17, 2017
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT02465255
Brief Title
Sublingual Analgesia for Acute Abdominal Pain in Children
Official Title
Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Acute Abdominal Pain, Sublingual Analgesia, Children, Ketorolac, Tramadol, Paracetamol, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Ketorolac 0.5 mg/kg administrated by sublingual route
Arm Title
Tramadol
Arm Type
Active Comparator
Arm Description
Tramadol 2.0 mg/kg administrated by sublingual route
Arm Title
Acetaminophen (paracetamol)
Arm Type
Active Comparator
Arm Description
Acetaminophen (paracetamol) 20.0 mg/kg administrated by sublingual route
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Primary Outcome Measure Information:
Title
Pain Score
Description
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Time Frame
120 minutes after drug administration
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Time Frame
30 minutes after drug administration
Title
Pain Score
Description
Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age
Time Frame
60 minutes after drug administration
Title
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Time Frame
24 hours after drug administration
Title
Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)
Time Frame
48 hours after drug administration
Title
Adverse events
Description
Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding
Time Frame
up to 180 hours after the drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidio Barbi, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elena Neri, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giorgio Cozzi, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Burlo Garofolo
City
Trieste
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

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Sublingual Analgesia for Acute Abdominal Pain in Children

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