Choi, H.S., Kim, K.O., Chun, H.J., Keum, B., Seo, Y.S., Kim, Y.S., . . . Ryu, H.S. (2012). The efficacy of transdermal fentanyl for pain relief after endoscopic submucosal dissection: A prospective, randomised controlled trial. Digestive and Liver Disease , 44, 925–929.

DOI Link

Study Purpose

To investigate the efficacy and safety of fentanyl patches for pain relief after endoscopic submucosal dissection

Intervention Characteristics/Basic Study Process

Patients were randomized to a fentanyl patch or placebo control group. Patients in the patch group were instructed in the use of the patch, which they applied the night before the procedure. Pain was assessed immediately before and immediately after the endoscopy. Maximum pain during the 24 hours following the endoscopy was assessed at discharge. All patients received IV propofol and cimetropium bromide during the procedure. Fentanyl patches used were 12 mcg patches.

Sample Characteristics

  • The sample was composed of 104 patients.   
  • Mean patient age was 62 years.
  • Of all patients, 71% were male and 29% were female.
  • Patients underwent a diagnostic endoscopy. Approximately two-thirds were diagnosed with dysplasia and one-third had early gastric cancer.

Setting

  • Single site
  • Inpatient
  • South Korea

Phase of Care and Clinical Applications

Phase of care: diagnostic

Study Design

Randomized double-blind placebo-controlled trial

Measurement Instruments/Methods

The study used a numeric rating scale to measure pain.

Results

  • Prior to the procedure, there were no differences between groups in regard to pain rating.
  • Right after the endscopy, average pain rating with placebo was 5.17 and with the fentanyl patch, 4.26 (p = 0.03).
  • Maximum pain in the 24 hours after the procedure was slightly lower in those using fentanyl (p = 0.03) than in the placebo group. One day after the procedure, pain was lower in the patch group (1.20) versus those on placebo (2.98) (p < 0.001).
  • There were no differences between groups in regard to side effects.

Conclusions

Findings show that fentanyl patches applied prior to endoscopic submucosal dissection are safe and effective in reducing postprocedural pain.

Limitations

  • Authors did not describe unintended interventions or applicable interventions that would have influenced results.
  • Authors do not state whether patients on placebo received any medication for pain.

Nursing Implications

Usual treatment for endoscopy pain can involve frequent injections. Since fentanyl patches can be applied prior to a procedure, they may provide more comfort than injected as-needed pain medications can. This study showed that, compared to placebo, a low-dose fentanyl patch applied prior to endoscopic dissection was effective in reducing pain and was not associated with adverse effects. The approach the study outlines is novel and may be applicable to various groups of patients who could experience acute pain.