None listed
Conditions
Brief summary
We set out to assess the impact of ondansetron on the incidence of vomiting in children undergoing procedural sedation and analgesia (PSA) with the combination of intranasal fentanyl (INF) and inhaled nitrous oxide (N2O) compared with placebo. We hypothesize that ondansetron can significantly decrease the rate of vomiting associated with the combination of INF and N2O. Currently, there exists no report of any strategy to reduce the occurrence of vomiting in patients receiving INF and N2O. This is a phase III, double-blinded, placebo-controlled superiority trial of ondansetron for prevention of vomiting associated with PSA with the combination of INF and N2O. Participants will be randomized to receive one dose of ondansetron oral syrup (4 mg for patients 15-30 kg; 8 mg for patients >30 kg) or matched placebo during PSA. The treatment period will be limited to the participants’ emergency visit requiring PSA. The follow-up period will be of a maximum of one week (aiming for less than 72 hours) for each individual, ending at the time of the phone follow-up. The primary outcome is to determine if ondansetron decreases the incidence of vomiting during PSA with the combination of INF and N2O in children aged between 3 and less than 18 years compared with placebo. Secondary outcomes are to determine the effect of ondansetron compared with placebo on: a. Number of vomits during PSA b. Vomiting in the PED after PSA d. Vomiting within 24 hours of the start of the procedure c. Retching during PSA d. Procedure duration e. Procedure abandonment f. PSA-associated adverse events during the emergency visit g. To explore parental satisfaction h. To explore value parents put on vomiting
Interventions
Single-dose of study drug (Ondansetron vs Placebo syrup) by mouth, 30 minutes prior to procedural sedation. The following weight-based dosing will be used:
15-30kg = 5 ml of study drug (Ondansetron 4 mg or Placebo)
over 30 kg = 10 ml of study drug (Ondansetron 8 mg or Placebo)
At the time of randomisation, the investigator will access the study drug supply in the paediatric emergency department and dispense to the participant the next available box containing the appropriate weight-based dose. A
Single-dose of study drug (Ondansetron vs Placebo syrup) by mouth, 30 minutes prior to procedural sedation. The following weight-based dosing will be used: 15-30kg = 5 ml of study drug (Ondansetron 4 mg or Placebo) over 30 kg = 10 ml of study drug (Ondansetron 8 mg or Placebo) At the time of randomisation, the investigator will access the study drug supply in the paediatric emergency department and dispense to the participant the next available box containing the appropriate weight-based dose. A research assistant may complete this task as long as it is counter-signed by a medically qualified staff.
Sponsors
Murdoch Children’s Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Be aged from 3 years to 18 years 2. Weight equal or greater than 15 kg 3. Planned procedural sedation with the combination of intranasal fentanyl and nitrous oxide 4. Have written informed consent provided by a parent or legal guardian. The participant may also provide consent if he/she is deemed competent.
Exclusion criteria
1. Contraindication to receiving intranasal fentanyl: opioid allergy and acute/chronic nasal problems 2. Contraindication to receiving nitrous oxide as per institutional sedation manual 3. Contraindication to receiving ondansetron or placebo: known arrhythmia, use of QT- prolonging drugs or allergy to any component of the ondansetron or placebo syrups 4. Cardiorespiratory instability 5. Decreased level of consciousness 6. Concomitant head injury 7. Planned use of additional sedatives
Outcome results
None listed