Comparison of Intravenous Tramadol vs Intranasal Fentanyl in the Postoperative pain relief of Head and Neck Cancer Patients: A Prospective double blinded Randomized control trial

Resumen

Aim: The purpose of this study is to evaluate the effectiveness of Intravenous tramadol and
Intranasal Fentanyl in postoperative breakthrough pain of head and neck cancer patient.
Materials and Methods: This was a single-center, parallel-group, single blinded randomized
control trial. A written informed consent was obtained from all the participants. Ethical
committee approval was obtained from the institutional ethical committee. The participants
involved in the study were patients affected by head and neck cancer and surgically treated in
the period between December 2020 and February 2021. This study was conducted in 20
patients who underwent similar surgery of wide local Excision and Modified Radical Neck
Dissection. 10 patients were allocated in each group. The patients were randomly allocated
into two groups. Group A received paracetamol 1 g iv every 8 hours; fentanyl 12 mcg/kg
intranasal when the patient complained of the first break through pain. Group B received
paracetamol 1 g IV every 8 hours and tramadol when the patient complained of first
breakthrough pain. Intranasal administration of the drug was done using a Mucosal
Atomisation device. Administration of the drugs was done by a single operator. The primary
outcome assessed was the pain which was rated using the visual analog scale (0 - no pain).
The time of onset of the action in both the groups was recorded. The duration of analgesia
was also assessed which was recorded in minutes. The secondary outcomes evaluated
included the heart rate, respiratory rate and the oxygen saturation. The outcomes were
monitored since both the drugs were known to cause respiratory depression
Results: A total of 20 patients were treated in this study Patients were observed for 24 hours
after the surgery. The visual analog scale indicated that significant reduction in pain was
observed in those who were administered intranasal Fentanyl. In group A and group B the
average score indicated on the visual analog scale was 3 and 6 respectively after the
administration of the drug. Action of Intranasal Fentanyl was faster when compared to
intravenous Tramadol. The time of onset for the action of the drug was an average of 30
seconds to 1 minutes in both the groups. Fentanyl showed a longer duration of action when
compared to tramadol. The duration of analgesia in group A and group B was an average of
120 minutes and 90 minutes respectively. Respiratory depression was noted in a few patients
administered with intravenous tramadol. No incidence of bradycardia, hypotension or
respiratory depression was noted in both the groups.
Conclusion: In this study, we conclude that the intranasal administration of Fentanyl
provides better post-operative breakthrough pain relief in head and neck cancer patient when
compared to intravenous tramadol.