B-CONVINCED: Beta-blocker CONtinuation Vs



Nebulized Fentanyl versus Intravenous Morphine in Children with Suspected Limb Fractures in the Emergency Department: A Randomized Controlled Trial

Furyk JS, Grabowski WJ, Black LH

Emergency Medicine Australasia 2009; 21: 203-9

Background:

• Children in pain require rapid, effective analgesia, and in severe pain this often requires im or iv administration of opioid analgesics

• Insertion of an im or iv cannula causes significant distress to the child and/or parents, and using a topical anesthetic to ease the insertion can result in delays of analgesia

• Therapeutic concentrations of opioids can be achieved through the inhalational route, based on pharmacokinetic studies. Thich may be a promising way to provide analgesia to pediatric patients rapidly and effectively

Study Objective:

• To compare the efficacy of nebulized fentanyl with iv morphine in pediatric patients presenting to the ED with clinically suspected limb fractures

Methods:

• Design:

o Single center, prospective, randomized controlled non-inferiority trial

▪ Mixed (adult and pediatric) tertiary hospital ED

o Consent obtained from parents, then treatment allocated

• Inclusion Criteria:

o Children 4-13 years old with pain from a clinically suspected limb fracture

o Pain had to be considered sufficient to warrant narcotic analgesia

• Exclusion Criteria:

o American Society of Anesthesiologists grade >1

o Chronic medical condition (ex. structural heart disease, hepatic, renal disease)

o Active asthma (requiring preventers or current wheeze)

o Concurrent URTI

o Allergy to fentanyl or morphine

• Intervention:

o Nebulized fentanyl 4mg/kg (maximum 200mg), made up to volume of 5mL with NS, in a standard nebulizer circuit, administered with oxygen

• Control:

o IV morphine 0.1mg/kg, following application of topical anesthetic cream

• Primary Endpoint:

o Decrease in pain scores at 15 and 30min

▪ Pain was measured using the Wong and Baker faces pain scale

▪ Pain measures were recorded by a separate doctor, unaware of the treatment allocation

• Fentanyl patients had a “fake cannula” site for concealment

[pic]

• Secondary Endpoints:

o Vital signs, Glasgow Coma Score, oxygen saturation

o Side effects

• Statistics:

o One unit on the pain scale was the margin of inferiority

▪ Based on minimum clinically significant difference in pain in children to be 10mm on a 100mm VAS

o Assuming a standard deviation of 1 pain unit in response to analgesia, a sample size of 64 was required to be adequately powered to show non-inferiority

o Decreases in pain scores compared using paired sample t-tests and the non-parametric Mann-Whitney test

• Results:

[pic]

[pic]

[pic]

•

o No significant change in heart rate, GCS score, or oxygen saturation

o 3 patients in the morphine group with adverse events:

▪ 1 with abdominal pain, 1 with rash to limb, 1 with nausea

o No adverse events in nebulized fentanyl group, but 1 patient was withdrawn because of perceived insufficient analgesia

Authors’ Conclusions:

• Nebulized fentanyl in a dose of 4mg/kg given via a standard nebulizer can provide clinically significant improvements in pain scores comparable to iv morphine

• Nebulized fentanyl should be considered as a treatment option for use in children presenting in acute pain

Funding/Sponsorship:

• No conflicts of interest declared, funding not mentioned

Limitations:

• Single centre, relatively small number of patients

o Site sees roughly 60,000 presentations in ED each year, 25% of which are pediatric

o Data was collected from January 2007 to February 2008

• Study protocol did not allow for titrated or repeated dosing

• Max dose was given for fentanyl (200mg), but not for morphine

• Limited patient population – only limb fracture patients… unclear how this would work with other types of pain

Application to Practice:

• Administering nebulized fentanyl in pediatric patients presenting with pain requiring narcotics may be equally as effective as iv or im narcotics, and will be much less distressing to patients and/or parents

• Evidence is rather limited, so performing our own study may help shed light on this topic and advance our care of pediatric patients

What some other studies have done:

Inclusion Criteria

• Adult patients1

• Weight 10-75kg, Age < 15, burns > 10% BSA with daily dressing changes2

• Children aged 7-15 with clinically suspected long limb fractures3

• Adult patients4

• Children 6mo-17 years who required iv pain medication but otherwise didn’t require iv placement5

Exclusion Criteria

• Burns to face make intranasal admin difficult, opiate allergy, extreme anxiety requiring po anxiolytics2

• Received narcotics 6yo5

Intervention

• Oral morphine 1mg/kg and intranasal placebo day 1, oral placebo and intranasal fentanyl 1.4mcg/kg day 22

• Intranasal fentanyl 1.4mcg/kg vs. iv morphine 0.1mg/kg, additional doses allowed q5min until pain relieved or max dose achieved3

• IV fentanyl 1.5mcg/kg vs. nebulized fentanyl 1.5 mcg/kg4

• IV fentanyl 1.5mcg/kg vs. nebulized fentanyl 3.0mcg/kg, total volume 5mL, in a breath-actuated nebulizer (Aero-eclipse)5

Blinding

• Randomised, double-blind2

• IV cannula in every patient, nasal atomizer for every patient3

• IV cannula for every patient, nebulizer for every patient4

• Non-blinded5

Outcomes

• Numeric rating scale (0-10) or Princess Margaret Hospital Pain Assessment Tool (faces)2

• 100mm VAS3

• Children under 6 – Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS), children above 6 – 100mm VAS5

1. Rickard 2007

2. Fentanyl intranasal 2005

3. Borlan 2007

4. Bartfield 2004

5. Miner 2007

jhfhjgl

-----------------------

This graph shows how nebulized fentanyl and iv morphine both had similar reductions in pain over time, inferring that nebulized fentanyl could be as effective at reducing pain as iv morphine.

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download