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.
PROMETHAZINE VC SYRUP
(PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)
Promethazine hydrochloride, a phenothiazine derivative. Phenylephrine hydrochloride is a sympathomimetic amine salt. Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg.
Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Clinical Trials Related to Promethazine VC (Promethazine / Phenylephrine)
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.
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department [Not yet recruiting]
Acute low back pain is a common cause for emergency department visits. Controversy remains
regarding the optimal medication for acute low back pain relief. The investigators
hypothesized that administration of pharmacological anxiolysis in addition to analgesia will
improve pain relief and patient management in the emergency department.
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine [Recruiting]
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
Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) [Recruiting]
The purpose of this study is to compare meperidine/midazolam with diphenhydramine,
meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation
methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine
and promethazine) will improve sedation.
Page last updated: 2009-01-21