Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Pain Clinical Trial

Official title:

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951963
• Other study ID #: A12-158
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age: 3-17 years old

• Condition (medical or trauma) requiring opioid pain management per standard of care

• Need to establish an IV per standard of care

• Treating physician agrees to manage the patient's pain with morphine following randomization.

Exclusion Criteria:

• Trauma Team Activation

• Known allergy to ketamine

• Family member unable/unavailable to provide informed consent

• When appropriate, patient unwilling to provide assent

• High suspicion of injury related to child abuse

• Patient and/or family member is non-English speaking

• Patient is incarcerated

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketamine

• Morphine

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Scale Rating Agreement Among Patient, Parent, and Research Staff	FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.; FLACC - Parents 30 Minutes Post dose; FLACC - Staff 30 Minutes Post dose; Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain.	Up to 3 hours post pain medication administration
Primary	Cumulative Narcotic Consumption	All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.	3 hours post study drug administration
Primary	Adverse Drug Reaction	Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.	3 hours post study drug administration