Ishihara, M., Ikesue, H., Matsunaga, H., Suemaru, K., Kitaichi, K., Suetsugu, K., . . . Japanese Study Group for the Relief of Opioid-Induced Gastrointestinal Dysfunction. (2012). A multi-institutional study analyzing effect of prophylactic medication for prevention of opioid-induced gastrointestinal dysfunction. Clinical Journal of Pain, 28, 373–381.

DOI Link

Study Purpose

To evaluate the effectiveness of prophylactic laxatives and antiemetics on constipation, nausea, and vomiting in patients with cancer receiving opioids for the first time.

Intervention Characteristics/Basic Study Process

Medical records were reviewed from 2009 to 2010 for patients experiencing constipation, nausea, or vomiting during the first week of opioid analgesic administration. Number of stools recorded was used in the analysis. Constipation was defined as a stool-free interval of at least 72 hours during the first week. One episode of vomiting was counted as evidence of vomiting. Nausea grading was recorded for seven days.

Sample Characteristics

  • The study reported on a sample of 619 patients.
  • Mean patient age was 66.8 years (range 53-81).
  • The sample was 63% male and 37% female.
  • Gastrointestinal and lung cancer were most prevalent, but the sample included a variety of disease sites.
  • Most patients were receiving extended-release oxycodone.
  • Patients were excluded if they were using transdermal opioids; undergoing surgery within the first week of receiving opioids; or experiencing continuous symptoms of constipation, nausea, or vomiting prior to opioid administration.

Setting

  • Multi-site
  • Setting type not specified
  • Japan

Phase of Care and Clinical Applications

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability to older adult and palliative care.

Study Design

This was a descriptive, retrospective study.

Measurement Instruments/Methods

National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 4.0, for nausea grading

Results

  • Incidence of constipation was 33.7% in those receiving prophylactic laxatives, compared to 54.6% in others (p < 0.001).
  • The most frequently used laxative was magnesium oxide. Some patients also received senna and other combined laxatives. 
  • No significant differences in efficacy existed among different laxatives.
  • Regression analysis showed that no laxative use, use of morphine formulation, and being aged 70 years or older were predictive of constipation (p < 0.01).
  • Odds ratio in favor of laxatives was 0.469 (95% confidence interval [0.231, 0.955], p = 0.037).
  • No effects were observed for use of prophylactic antiemetics on nausea or vomiting. Antiemetics used were prochlorperazine, domperidone, and metoclopramide.

Conclusions

Use of prophylactic laxatives in patients receiving opioids for the first time was effective in reducing the risk and prevalence of constipation.

Limitations

  • A risk of bias existed because of the lack of random assignment.
  • Measurement validity and reliability were questionable.
  • The descriptive study design with dependence on medical record documentation limited the data's reliability.
  • The duration of observation was short at only one week. Longer term efficacy is not known. 
  • Dosages of opioids and other factors that could have contributed to constipation were not described.

Nursing Implications

Findings suggested use of prophylactic laxatives can reduce opioid-induced constipation during the first week in which patients receive opioids. Findings also suggested older patients may be at greater risk for opioid-induced constipation. Nurses can ensure that prophylactic regimens to prevent constipation are suggested for patients beginning opioid use and older adult patients.