PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
Clinical Trials Related to Promethazine DM (Dextromethorphan / Promethazine)
A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery [Recruiting]
Pain after ambulatory surgery remains an unsolved problem in The United States and Europe.
It is associated with delayed hospital discharge and it can result to an increased opioid
consumption with adverse side effects. The concept of multimodal analgesic technique was
introduced more than 15 years ago and several techniques have been studied over the years
including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids,
ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal
nociceptors and C-fibers, producing pain which is further increased by neurogenically
mediated release of substance P from afferent pain fibers. Several non-selective or H1
- selective histamine receptors antagonists have been demonstrated in animal models and
clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing
properties without adverse sedative effects in patients undergoing abdominal hysterectomy.
Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing
postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative
pain and other important outcomes after ambulatory surgery such as time to meet discharge
criteria have not being studied.
The MQOR 40 is a validated instrument that was specifically design to evaluate patient
recovery after anesthesia and surgery. This instrument can be particularly valid to examine
interventions which affect different spheres of patient recovery as is the case of
diphenhydramine. The objective of this study is to determine a dose response effect of
preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery.
The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease
postoperative pain, opioid consumption and opioid related side effects after ambulatory
The research question: Does a preoperative dose of diphenhydramine improve postoperative
quality of recovery after ambulatory surgery? The hypothesis of this study is that
preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and
vomiting (PONV), sleep which will translate in a better overall quality of recovery.
Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea [Recruiting]
This randomized clinical trial studies lorazepam, diphenhydramine hydrochloride, and
haloperidol gel in patients with nausea. Lorazepam, diphenhydramine hydrochloride, and
haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting [Recruiting]
This study is being done to determine the efficacies of two preventative drug combinations
for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this
study is to compare the efficacy of using aprepitant instead of ondansetron in combination
with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By
completing this comparison study investigators will determine the most efficacious drug
combination which will allow us to enhance the overall comfort and satisfaction of
neurosurgical patients in the immediate postoperative period.
Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED [Recruiting]
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy in Young Patients With Newly Diagnosed Cancer [Recruiting]
RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea
and vomiting in patients treated with chemotherapy. It is not yet known whether
diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in
treating nausea and vomiting caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and
dexamethasone to see how well they work compared with standard therapy in treating nausea and
vomiting caused by chemotherapy in young patients with newly diagnosed cancer.