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A randomized clinical trial of oral transmucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries.
Pediatr Emerg Care. 2007 Aug; 23(8):544-8.PE

Abstract

BACKGROUND

Extremity injury is a common condition that requires pain management in an emergency department. In pediatric patients, the most frequently used method of pain control is intravenous (IV) morphine sulfate. Oral transmucosal fentanyl citrate (OTFC) is a potential alternative to morphine, which may obviate the need to place an IV before addressing pain.

OBJECTIVE

To compare OTFC with IV morphine for sedation and analgesia during initial evaluation of children with deformity of an extremity and suspected fracture.

DESIGN/METHODS

A randomized controlled trial of OTFC versus IV morphine in which 8- to 18-year-olds presenting to pediatric tertiary care emergency department with extremity deformity and suspected fracture were eligible. Only those with visual analog scale (VAS) (0 = no pain, 100 = worst pain imaginable) score equal to or greater than 50/100, and American Society of Anesthesia I or II qualified. Patients were excluded if history of loss of/altered level of consciousness, multiple traumatic injuries, or if patient had received prior medication for pain control. All patients enrolled were randomly assigned to receive either IV morphine (0.1 mg/kg) or OTFC (10-15 mug/kg). Patients rated pain intensity using VAS; scores were recorded before medicating and at 15-minute intervals after the medication was given. Adverse events such as emesis, pruritus, and respiratory depression were recorded.

RESULTS

A total of 87 patients were enrolled in study (OTFC, 47; morphine, 40). There are no significant differences between the 2 groups when comparing sex, age, weight, and pretreatment VAS score (P > 0.05). Although the VAS scores were not significantly different before medicating the patient, an analysis of variance shows that there was a significant difference (P > 0.05) in VAS scores at 30 minutes. The differences persisted for every 15 minutes through the 75 minutes of monitoring. There was no statistically significant difference between the 2 groups when comparing the number of adverse events (P = 0.23).

CONCLUSIONS

The use of OTFC can provide improved pain control when compared with IV morphine. The pain reduction starts 30 minutes after initiation of medication, and the effect is seen as far as 75 minutes after the initiation of analgesic medication. The study size was too small to make any statements concerning adverse effects; thus, further studies with larger sample sizes are needed to determine the use of OTFC.

Authors+Show Affiliations

Division of Emergency Medicine, Department of Pediatrics The Children's Hospital, University of Colorado School of Medicine, Denver, CO, USA. mahar.patrick@tchden.orgNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

17726413

Citation

Mahar, Patrick J., et al. "A Randomized Clinical Trial of Oral Transmucosal Fentanyl Citrate Versus Intravenous Morphine Sulfate for Initial Control of Pain in Children With Extremity Injuries." Pediatric Emergency Care, vol. 23, no. 8, 2007, pp. 544-8.
Mahar PJ, Rana JA, Kennedy CS, et al. A randomized clinical trial of oral transmucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries. Pediatr Emerg Care. 2007;23(8):544-8.
Mahar, P. J., Rana, J. A., Kennedy, C. S., & Christopher, N. C. (2007). A randomized clinical trial of oral transmucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries. Pediatric Emergency Care, 23(8), 544-8.
Mahar PJ, et al. A Randomized Clinical Trial of Oral Transmucosal Fentanyl Citrate Versus Intravenous Morphine Sulfate for Initial Control of Pain in Children With Extremity Injuries. Pediatr Emerg Care. 2007;23(8):544-8. PubMed PMID: 17726413.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized clinical trial of oral transmucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries. AU - Mahar,Patrick J, AU - Rana,Jamal A, AU - Kennedy,Christopher S, AU - Christopher,Norman C, PY - 2007/8/30/pubmed PY - 2007/11/8/medline PY - 2007/8/30/entrez SP - 544 EP - 8 JF - Pediatric emergency care JO - Pediatr Emerg Care VL - 23 IS - 8 N2 - BACKGROUND: Extremity injury is a common condition that requires pain management in an emergency department. In pediatric patients, the most frequently used method of pain control is intravenous (IV) morphine sulfate. Oral transmucosal fentanyl citrate (OTFC) is a potential alternative to morphine, which may obviate the need to place an IV before addressing pain. OBJECTIVE: To compare OTFC with IV morphine for sedation and analgesia during initial evaluation of children with deformity of an extremity and suspected fracture. DESIGN/METHODS: A randomized controlled trial of OTFC versus IV morphine in which 8- to 18-year-olds presenting to pediatric tertiary care emergency department with extremity deformity and suspected fracture were eligible. Only those with visual analog scale (VAS) (0 = no pain, 100 = worst pain imaginable) score equal to or greater than 50/100, and American Society of Anesthesia I or II qualified. Patients were excluded if history of loss of/altered level of consciousness, multiple traumatic injuries, or if patient had received prior medication for pain control. All patients enrolled were randomly assigned to receive either IV morphine (0.1 mg/kg) or OTFC (10-15 mug/kg). Patients rated pain intensity using VAS; scores were recorded before medicating and at 15-minute intervals after the medication was given. Adverse events such as emesis, pruritus, and respiratory depression were recorded. RESULTS: A total of 87 patients were enrolled in study (OTFC, 47; morphine, 40). There are no significant differences between the 2 groups when comparing sex, age, weight, and pretreatment VAS score (P > 0.05). Although the VAS scores were not significantly different before medicating the patient, an analysis of variance shows that there was a significant difference (P > 0.05) in VAS scores at 30 minutes. The differences persisted for every 15 minutes through the 75 minutes of monitoring. There was no statistically significant difference between the 2 groups when comparing the number of adverse events (P = 0.23). CONCLUSIONS: The use of OTFC can provide improved pain control when compared with IV morphine. The pain reduction starts 30 minutes after initiation of medication, and the effect is seen as far as 75 minutes after the initiation of analgesic medication. The study size was too small to make any statements concerning adverse effects; thus, further studies with larger sample sizes are needed to determine the use of OTFC. SN - 1535-1815 UR - https://www.unboundmedicine.com/medline/citation/17726413/A_randomized_clinical_trial_of_oral_transmucosal_fentanyl_citrate_versus_intravenous_morphine_sulfate_for_initial_control_of_pain_in_children_with_extremity_injuries_ DB - PRIME DP - Unbound Medicine ER -