Dataset Information

Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone.

ABSTRACT:

Introduction

There has been an exponential increase in the number of ambulatory surgeries (AS). Pain and postoperative nausea vomiting (PONV) affects the recovery, discharge and overall satisfaction of patients having AS. Opioids remain the primary modality for moderate to severe pain. Since there is no perfect opioid, physicians should ideally use the opioid that optimally balances benefits and risks. Present decisions on the choice between morphine (M) and hydromorphone (HM) are based on individual experience and observation. Our primary objective is to compare the proportion of patients having AS achieving satisfactory analgesia without significant PONV when using M compared with HM. Secondarily we will compare the proportion of patients with adverse events, analgesic used, patient satisfaction, time to discharge and postdischarge symptoms.

Methods and analysis

This is a two-arm, multicentre, parallel group, randomised controlled trial of 400 patients having AS. Eligible patients undergoing AS of the abdominal and pelvic regions with a potential to cause moderate to severe pain will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomised to M or HM. Patients, healthcare providers and research personnel will be blinded. Study interventions will be administered in the recovery using equianalgesic doses of M or HM in concealed syringes. Patients will be followed in hospital and up to 3 months. Intention-to-treat approach will be used for analysis.

Ethics and dissemination

This study has been approved by the Hamilton integrated research ethics board. We plan to publish our trial findings and present our findings at scientific meetings.

Trail registration number

NCT02223377; Pre-results.

SUBMITTER: Shanthanna H

PROVIDER: S-EPMC6020940 | biostudies-literature |

REPOSITORIES: biostudies-literature

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