Morphine Mouthwash

Morphine Mouthwash

PEP Topic 
Acute Pain
Description 

Researchers have examined the effect, on acute pain from oral mucositis caused by cancer, of a mouthwash containing a morphine solution. 

Effectiveness Not Established

Research Evidence Summaries

Nielsen, B.N., Aagaard, G., Henneberg, S.W., Schmiegelow, K., Hansen, S.H., & Romsing, J. (2012). Topical morphine for oral mucositis in children: Dose finding and absorption. Journal of Pain and Symptom Management, 44(1), 117–123.

doi: 10.1016/j.jpainsymman.2011.06.029
Print

Study Purpose:

To investigate the dose-response relationship of topical morphine and pain in pediatric cancer patients with oral mucositis; to investigate, after topical morphine administration, the plasma levels of morphine and metabolites
 

Intervention Characteristics/Basic Study Process:

The sample included 12 children receiving treatment for chemotherapy-induced oral mucositis. Seven patients were in the dose-response study and five were in the absorption group.

Both groups received oral morphine for pain relief. All children in the study received an oral solution containing morphine hydrochloride, 1 or 2 mg/ml, administered as a spray by means of an atomizer. The child was then to retain the solution in the mouth for 10 seconds before spitting out the solution. All children in the study also received 10‐15 mg/kg acetaminophen every 6 hours. Supplemental analgesics were allowed in the study either by patient-controlled analgesia pump or intravenously.
 

Sample Characteristics:

  • The sample was composed of 12 patients.                         
  • Mean patient age was 9 years (SD = 7 years). In the dose-relationship study, the age range of participants was 6‐15 years, with the mean age being 8 years. In the absorption study, the age range of participants was 2‐17 years, with mean age being 10.4 years.
  • Of all participants, 66.6% were male and 33.3% were female.
  • Diagnoses in both groups were varied and included non-Hodgkin lymphoma (NHL); neuroblastoma (NBL); hematopoietic stem cell transplantation (HSCT), including concomitant radiation therapy; and acute lymphoblastic leukemia (ALL). ALL was the most common diagnosis. The list that follows specifies diagnosis by percentage of all patients.
    • 50% (n = 6) ALL.
    • 16.6% (n = 2) NHL.
    • 25% (n = 3) NBL.
    • 8.3% (n = 1) HSCT, including concomitant radiation therapy.

Setting:

  • Single site
  • Inpatient
  • Department of Pediatrics, Copenhagen University Hospital, Sweden

Phase of Care and Clinical Applications:

  • Phase of care: active treatment
  • Clinical application: pediatrics

 

Study Design:

Prospective observational sequential study

Measurement Instruments/Methods:

  • Age-appropriate 11-point pain scale, to assess pain intensity, with 0 = no pain and 10 = worst pain
  • Visual analog scale (VAS), 0–10, for children older than age 8
  • Wong-Baker FACES Pain Rating Scale, a VAS consisting of six faces, to assess the pain of children ages 6–8
  • Face, Legs, Activity, Cry, Consolability (FLACC) Scale, composed of five behavioral components to access the pain of preverbal children age 5 and younger
  • World Health Organization (WHO) Oral Mucositis Scale, on which 0 = no oral mucositis and 4 = severe oral mucositis
  • Analysis of plasma and metabolites to show morphine level

Results:

In the dose-response group, the morphine mouthwash was associated with a decrease of at least 36% in the oral pain score of six of seven patients. Thirty minutes after topical doses of 0.25–0.4 mg/kg morphine, pain decreased by approximately 36%. The absorption study reported concentrations of morphine and metabolites well below effective analgesic levels; authors reported no increase in plasma concentration of morphine.

Conclusions:

The extremely small sample size prevents applying study results to the pediatric population of patients diagnosed with oral mucositis. Further research should investigate the reliability of these findings.
 

Limitations:

  • The study had a small sample size, with fewer than 30 patients.
  • The use of a systemic opiod as a rescue medication may have caused inconsistent results.

 

Nursing Implications:

The evidence from this study is insufficient to allow researchers to draw conclusions about the effect of topical morphine on the pain associated with oral mucositis. However, oral analgesics such as morphine could be effective supplements, causing few side effects, to established treatments. More research is needed.
 

Vayne-Bossert, P., Escher, M., de Vautibault, C., Dulguerov, P., Allal, A., Desmeules, J., . . . Pautex, S. (2010). Effect of topical morphine (mouthwash) on oral pain due to chemotherapy- and/or radiotherapy-induced mucositis: A randomized double-blinded study. Journal of Palliative Medicine, 13(2), 125–128.

doi: 10.1089/jpm.2009.0195
Print

Study Purpose:

To determine if a mouthwash containing morphine decreases oral pain associated with chemotherapy- or radiotherapy-induced mucositis

Intervention Characteristics/Basic Study Process:

Subjects were randomized to two groups. One used 2% morphine solution. The other used a placebo, a quinine solution. Both groups used the specified solution six times daily, holding the solution in the mouth for 2 minutes at each application. After three days patients crossed over to the alternate treatment. Patients kept daily diaries and rated oral pain before and one hour after the mouthwash. The study lasted six days.

Sample Characteristics:

  • The sample was composed of 11 patients.
  • Mean patient age was 55.1 years (SD = 3 years).
  • The report did not state the percentages of males and females in the sample.
  • The report did not state key disease characteristics.
  • All patients were receiving either chemotherapy or radiotherapy. Most patients used acetaminophen and NSAIDs for pain; three patients used opiods.
     

Setting:

  • Multisite
  • Clinical
  • Switzerland
     

Phase of Care and Clinical Applications:

Phase of care: active treatment

 

Study Design:

Randomized double-blind crossover study

Measurement Instruments/Methods:

The study used a 10 cm visual analog scale (VAS), to rate pain.

Results:

ANOVA suggested a difference over time between placebo and morphine, but authors noted no significant differences in pain between mouthwashes on the same or different days. Not all patients adhered to prescribed frequency of use. Authors noted no adverse events.

Conclusions:

Study results did not support the use of morphine mouthwash as a treatment for the pain of oral mucositis.

Limitations:

  • The study had a small sample size, with fewer than 30 patients.
  • The study had a risk of bias resulting from sample characteristics.
  • Other possible study limitations were short duration; low pain levels, given the medications used; and lack of information about rescue medication. The study did not consider how many subjects may have been receiving multiple treatments, a factor that might have affected mucositis. The frequency of mouthwash use, to achieve effective pain relief, is unknown.

Nursing Implications:

This study was too small to demonstrate the effects of a morphine-containing mouthwash on mucositis-associated oral pain.


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