Sublingual Analgesia for Acute Abdominal Pain in Children

Abdominal Pain Clinical Trial

Official title:

Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465255
• Other study ID #: RC 22/13
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2015
• Last updated: August 17, 2017
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Drug:
• Ketorolac

• Tramadol

• Acetaminophen

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age	120 minutes after drug administration
Secondary	Pain Score	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age	30 minutes after drug administration
Secondary	Pain Score	Pain score evaluated with visual analogical scale (VAS) or Numeric Rating Scale (NRS) depending on child age	60 minutes after drug administration
Secondary	Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)		24 hours after drug administration
Secondary	Missed or delayed diagnosis of acute appendicitis or other abdominal pathology (i.e., pancreatitis)		48 hours after drug administration
Secondary	Adverse events	Presence of nausea, vomiting, diarrhea, headache, hyper- or hypotension, decreased excretion of urine, bleeding	up to 180 hours after the drug administration