Mercadante, S., Arcuri, E., Fusco, F., Tirelli, W., Villari, P., Bussolino, C. ... Ripamonti, C. (2005). Randomized double-blind, double-dummy crossover clinical trial of oral tramadol versus rectal tramadol administration in opioid-naive cancer patients with pain. Supportive Care in Cancer, 13, 702–707.doi: 10.1007/s00520-004-0760-9
To compare the analgesic activity and tolerability of orally administered and rectally administered tramadol
In this crossover trial, 30 patients started with orally administered tramadol and switched to rectally administered tramadol and 30 patients started with rectally administered tramadol and switched to orally administered tramadol.
The study was conducted in Italy.
Multicenter, randomized double-blind, double-dummy crossover trial
Rectal administration of tramadol appears to be a reliable, noninvasive alternative method of pain control for patients who are no longer responsive to nonopioid analgesics and who are unable to take oral tramadol. Rectal administration of tramadol appears to be as safe and effective as oral administration.
The study had a high dropout rate, with 25% of patients dropping out.
Rectal irritation has occurred with rectal administration of tramadol. If the patient is neutropenic or thrombocytopenic, rectal administration may be contraindicated. Patients with diarrhea will have difficulty maintaining and absorbing tramadol. Patients with lack of rectal tone will not be able to keep the suppository in the rectal vault.