Oral Promethazine Research Articles

Case Analysis of Sprint Interval Training for Adolescents With Severe Mental Illness

Case Analysis of Sprint Interval Training for Adolescents With Severe Mental Illness

Chloral hydrate as a sedating agent for neurodiagnostic procedures in children.

Chloral hydrate as a sedating agent for neurodiagnostic procedures in children.

Porównanie sedacji pediatrycznej przy zastosowaniu podawanych doustnie midazolamu i ketaminy oraz midazolamu i prometazyny

Porównanie sedacji pediatrycznej przy zastosowaniu podawanych doustnie midazolamu i ketaminy oraz midazolamu i prometazyny

Promethazine and Oral Midazolam Preanesthetic Children Medication.

Several kinds of drugs have been investigated in preschool children as a preanesthetic sedation after various routes of administration for surgeries. This study aims to compare the efficacy of promethazine and oral midazolam for premedication in children aged 3 to 9 years who were scheduled for surgeries. This is a double-blind randomized controlled study conducted on 93 patients between the age of 3 and 9 years at Loresten University of Medical Sciences Teaching Hospital, Khoramabad, Iran. The subjects were grouped into P (promethazine), M (midazolam), and C (control). About 0.3 mg/kg of oral promethazine was administered to patients in group P, 0.5 mg/kg of oral midazolam was administered to patients in group M, and 3 mL of normal saline as placebo was administered to patients in group C. Patient satisfaction, sedation and emotional score, systolic blood pressure (SBP), diastolic blood pressure, respiratory rate (RR), and heart rate (HR) were recorded. There was no statistically significant difference among the 3 groups. However, the period after medication, it was observed that SBP, diastolic blood pressure, RR, and HR in group C were statistically significantly higher than those in groups M and P. These 2 groups are similar in terms of SBP, RR, and HR. The emotional scores were comparable for the 2 groups. It was between 3.97 ± 0.6 to 1.7 ± 0.5 in group M and from 3.45 ± 1.17 to 2.745 ± 0.997 in group P in a Kruskal-Wallis test. This study shows that both test groups reduce stress at the time of anesthetic induction and separation from their parents with similar effect. Both of the anesthetics are easily administered without the necessity of an additional equipment. A shorter period to maximal sedation for midazolam is an advantage, thus, making the drug helpful, mostly in the outpatient setting.

Chloral hydrate as a sedating agent for neurodiagnostic procedures in children.

Chloral hydrate as a sedating agent for neurodiagnostic procedures in children.

The Impact of Oral Promethazine on Human Whole-Body Motion Perceptual Thresholds.

Despite the widespread treatment of motion sickness symptoms using drugs and the involvement of the vestibular system in motion sickness, little is known about the effects of anti-motion sickness drugs on vestibular perception. In particular, the impact of oral promethazine, widely used for treating motion sickness, on vestibular perceptual thresholds has not previously been quantified. We examined whether promethazine (25mg) alters vestibular perceptual thresholds in a counterbalanced, double-blind, within-subject study. Thresholds were determined using a direction recognition task (left vs. right) for whole-body yaw rotation, y-translation (interaural), and roll tilt passive, self-motions. Roll tilt thresholds were 31% higher after ingestion of promethazine (P=0.005). There were no statistically significant changes in yaw rotation and y-translation thresholds. This worsening of precision could have functional implications, e.g., during driving, bicycling, and piloting tasks. Differing results from some past studies of promethazine on the vestibulo-ocular reflex emphasize the need to study motion perception in addition to motor responses.

(119) A Comparative Study on the Sedative Effect of Oral Midazolam and oral Promethazine Medication in lumbar puncture

Lumbar puncture (LP) essentially is a painful and stressful procedure that indicated for diagnosis and therapeutic purposes. One way to reduce the anxiety is oral premedication. The aim of this study is to compare clinical effects of oral Midazolam and oral Promethazine. This prospective randomized controlled clinical trial study was performed on 80 children 2-7 years old were candidate for LP. They were divided into two randomized equal groups. First group received oral Midazolam syrp 0.5 mg/kg and the other group received oral Promethazine syrp 1 mg/kg. Level of sedation, hemodynamic changes and any other complications monitored every 5 minutes from 30 minutes before the start of the procedure. Midazolam group and Promethazine group were similar in age, gender and weight. Oral Midazolam significantly had shorter onset of sedation (P<0.001) and also shorter duration to maximal sedation (P<0.022). The two groups were similar with respect to sedative effect at all time. The only complication that was significantly more in Midazolam group, nausea and vomiting (P<0.012). Midazolam syrp and Promethazine syrp have same sedative effect in children. Both of these medications are easy to use in preschool children and none of them appeared to be superior to another.

ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a P2 study in Indian women with recurrent/refractory cervical cancer.

5529 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized P2 study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients were randomized to either 3 doses of ADXS11-001 at 1 x 109 cfu or 4 doses of ADXS11-001 at 1 x 109cfu with cisplatin chemotherapy. Naprosyn and oral promethazine were given as premedications and a course of ampicillin was given 72h after infusion. Patients received CT scans at baseline and 3, 6, 9, 12 and 18 months. The primary endpoint is overall survival. Results: As of February 2013, the trial has completed enrollment and 110 patients have received 264 doses of ADXS11-001. The percentage of patients alive at 6 months is 63% (67/107); at 9 months is 46% (49/106); at 12 months is 34% (30/87) and at 18 months is 15% (8/54). Tumor responses have been observed in both treatment arms with 6 CRs and 6 PRs; 36 additional patients had stable disease &gt; 3 months, for a disease control rate of 44% (48/110). Activity against different high risk HPV strains has been observed. Three serious adverse events and 69 mild-moderate adverse events possibly related/related to ADXS11-001 treatment have been reported in 41% (45/110) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that either resolved on their own or responded to symptomatic treatment. Conclusions: ADXS11-001 can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Final 12-month OS, updated safety and translational analyses will be presented at the meeting.

A comparative study of the sedative effect of oral midazolam and oral promethazine medication in lumbar puncture.

Lumbar puncture (LP) essentially is a painful and stressful procedure, however indicated for diagnosis and therapeutic purposes. One way to reduce the anxiety is to administer an oral premedication. The aim of this study is to compare clinical effects of oral midazolam and oral promethazine in LP. This prospective randomized controlled clinical trial study was performed on 80 children aged 2-7 years that were candidate for LP. They were divided into two randomized equal groups. First group received oral midazolam syrup 0.5 mg/kg and the other group received oral promethazine syrup 1mg/kg. Level of sedation, hemodynamic changes and any other complications were monitored every 5 minutes from 30 minutes before the start of the procedure. Midazolam group and promethazine group were similar in age, gender and weight. Midazolam had significantly shorter onset of sedation and also shorter duration to maximal sedation. The two groups were similar with respect to sedative effect at all time. The only complication that was significantly more in midazolam group was nausea and vomiting. Midazolam syrup and promethazine syrup have same sedative effect in children. Both of these medications are easy to use in preschool children and none of them appeared to be superior to another.

ADXS11-011 immunotherapy: Preliminary safety data from two P2 studies in women with CIN 2/3 and with recurrent/refractory cervical cancer.

e15546 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized phase II study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients are randomized to either 3 doses of ADXS11-001 at 1 x 109 CFU or 4 doses of ADXS11-001 at 1 x 109 CFU with cisplatin chemotherapy. Naprosyn and oral promethazine are given as premedications and a course of ampicillin is given 72h after infusion thereby clearing any residual vector. Patients receive CT scans at baseline and Days 84, 184, 273, 365 and 545. The primary endpoint is 12 month survival. Results: As of January 26, 2012, 88 patients have received 200 doses of ADXS11-001; with the percentage of patients alive at 6 months at 62% (34/55); at 9 months at 41% (15/37) and at 12 months at 40% (6/15). Tumor responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) by RECIST. One serious (Gr3) adverse event and 77 mild-moderate (Gr 1-2) adverse events possibly related to study treatment have been reported in 35% (31/88) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that responded to symptomatic treatment, or resolved on their own within hours of treatment. Conclusions: This immunotherapy can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Early signs of clinical benefit merit further investigation. Updated findings will be presented at the meeting.

ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a phase II study in Indian women with recurrent/refractory cervical cancer.

5106 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized phase II study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients are randomized to either 3 doses of ADXS11-001 at 1 x 109 CFU or 4 doses of ADXS11-001 at 1 x 109 CFU with cisplatin chemotherapy. Naprosyn and oral promethazine are given as premedications and a course of ampicillin is given 72h after infusion thereby clearing any residual vector. Patients receive CT scans at baseline and Days 84, 184, 273, 365 and 545. The primary endpoint is 12 month survival. Results: As of January 26, 2012, 88 patients have received 200 doses of ADXS11-001; with the percentage of patients alive at 6 months at 62% (34/55); at 9 months at 41% (15/37) and at 12 months at 40% (6/15). Tumor responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) by RECIST. One serious (Gr3) adverse event and 77 mild-moderate (Gr 1-2) adverse events possibly related to study treatment have been reported in 35% (31/88) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that responded to symptomatic treatment, or resolved on their own within hours of treatment. Conclusions: This immunotherapy can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Early signs of clinical benefit merit further investigation. Updated findings will be presented at the meeting.

Preanesthetic sedation of preschool children: Comparison of intranasal midazolam versus oral promethazine.

Background:Ensuring adequate preoperative sedation and anxiolysis is essential, especially in pediatric surgery. Various drugs and routes of administration have been evaluated to determine the optimal method of sedation.Materials and Methods:We selected hundred preschool children undergoing elective surgery and sedated them with either intranasal midazolam or oral promethazine syrup in the preoperative period. They were assessed with respect to their levels of sedation till the period of mask placement for induction of general anesthesia.Results:Both groups had comparable heart rates, respiratory rates, sedation scores, and emotional scores at all points of assessment (P>0.05). However, intranasal midazolam had a significantly shorter onset of sedation as well as time to reach maximal sedation (P<0.001).Conclusion:We conclude that either drug may be used with ease in preschool children undergoing elective surgery.

Temporomandibular dislocation due to aripiprazole induced dystonia

We wish to report the case of a patient who developed temporomandibular joint dislocation due to dystonia following a single dose of aripiprazole. Our patient was a 23-year-old woman presenting with persistent low mood, fatiguability, insomnia and suicidal ideation. There was no past history of psychiatric morbidity. There was family history of depressive episode and deliberate self harm in her husband who was her paternal cousin. She was given 10 mg escitalopram and 0.5 mg clonazepam for insomnia on a diagnosis of a moderate depressive episode and improved over the next 3 weeks. However she developed irritability and agitation while on the above medications for which she was given a single dose of aripiprazole 10 mg at night by another psychiatrist not attached to our institution, which was not appropriate for her condition. The patient had taken 10 mg escitalopram in the morning. There was no history of intake of any over the counter drugs or herbal preparations. Twelve hours after the first dose she developed sedation and salivation and her care givers withheld subsequent doses of aripiprazole, escitalopram and clonazepam. Twenty hours after the first dose, she developed painful spasms of the muscles of her neck on the right side. She also had forced opening and deviation of jaw, both to the left and right. This was followed by persistent deviation of the jaw to the left and pain in the left temporomandibular joint. She was unable to close her mouth, swallow or talk for which she was brought to the emergency department of our hospital. A left-sided temporomandibular dislocation was diagnosed and a manual reduction was performed, after which the pain subsided. The next morning she was examined by us and seen to have forced mouth opening, excessive salivation and bilateral hand tremors. There were no other dystonic reactions. The dystonia and temporomandibular joint dislocation could not be part of the somatic symptoms of depression. We gave her 50 mg promethazine intramuscularly on suspicion of an aripiprazole induced dystonia. Two hours later, the dystonic movements subsided and the patient was sent home on oral promethazine. She did not have dystonic movements on follow-up the next morning. A rechallenge with aripiprazole could not be done for ethical reasons. The dystonia was rated as possibly due to aripiprozole according to the Naranjo adverse drug reaction probability scale [1]. She was restarted on escitalopram and clonazepam. A 1 month follow-up did not reveal any dystonic reactions. The adverse drug reaction was reported to the regional pharmacovigilance reporting centre. Aripiprazole is a second generation anti-psychotic which has a low propensity to cause extra-pyramidal side effects [2]. There are reports of acute dystonia induced by aripiprazole in drug-naive [3], and cocaine dependent patients [4] and in a patient on sertraline [5]. It has been proposed that aripiprazole caused dystonia because it lacked a protective anti-cholinergic action unlike other second generation anti-psychotics like clozapine [3]. Temporomandibular joint dislocations have been reported with conventional neuroleptics [6, 7] but no case has been reported with aripiprazole. Aripiprazole has been found to have no meaningful effect on the pharmacokinetics of escitalopram [8].We propose that our patient developed temporomandibular dislocation due to a dystonic reaction to aripiprazole possibly mediated through a pharmacodynamic synergism with escitalopram as selective serotonin re-uptake inhibitors can cause extrapyramidal side effects including dystonias through serotonergically mediated inhibition of the dopaminergic system [9]. From our case report we recommend a lower starting dose of aripiprazole especially in drug naive non psychotic patients and close monitoring of such patients.

Antihistamines are superior to topical steroids in managing Human Immunodeficiency Virus (HIV)‐associated papular pruritic eruption

Papular pruritic eruption (PPE) is a frequent HIV-comorbidity in tropical countries. Because of constant itching and social stigma, effective treatment is highly valued. In our HIV cohort in rural Tanzania with 12% prevalence of PPE, we have retrospectively analyzed responses to available treatments. Oral promethazine improved itching (P < 0.0058) and clinical scores (P < 0.032) significantly more than topical steroids. Disease activity did not correlate with CD4+ and CD8+ T cell counts and was independent of anti-retroviral medication. Therefore, oral antihistamines are an effective first-line treatment for PPE.

Double-blind comparison of granisetron, promethazine, or a combination of both for the prevention of postoperative nausea and vomiting in females undergoing outpatient laparoscopies

Postoperative nausea and vomiting (PONV) and postdischarge nausea and vomiting (PDNV) are common problems after surgery. Prophylactic combination antiemetic therapy is recommended for patients at high risk for developing PONV and PDNV. Granisetron, a serotonin antagonist, is an effective antiemetic that is devoid of sedative side effect. Although promethazine is effective, commonly used doses are associated with sedation. This study investigates the combination of low doses of granisetron and promethazine for the prevention of PONV. Women undergoing ambulatory gynecological laparoscopy were enrolled. A standard general anesthetic regimen was prescribed. Fifteen minutes before the expected end of surgery, the patients were randomly assigned to receive granisetron 0.1 mg iv, promethazine 6.25 mg iv, or a combination of the two drugs. Prophylaxis with oral promethazine 12.5 mg, granisetron 1 mg, or both was started in the respective groups 12 hr after the end of surgery and continued every 12 hr until postoperative day 3 (a total of five oral doses). The following outcomes were recorded: total response rate (defined as no vomiting, no more than mild nausea, and no use of rescue antiemetic); incidence of nausea, vomiting, and use of rescue antiemetics; severity of nausea; patient activity level; and patient satisfaction with PONV management. Patients in the combination group had a higher total response rate at 6, 24, 48, and 72 hr after surgery compared with those who received promethazine alone (at 24 hr, Combination 69.6%, Promethazine 36.2%, Granisetron 53.3%; P = 0.0079). The maximum nausea scores were also lower in the combination group at 6, 24, 48, and 72 hr (Combination 1.7 +/- 2.2, Promethazine 4.0 +/- 3.6, Granisetron 3.1 +/- 3.2 at 24 hr; P < 0.05). There was no difference in the sedation scores, incidence of drowsiness, patient activity level, and satisfaction with PONV management. Low-dose granisetron and promethazine combination was more effective in reducing PONV and PDNV than promethazine monotherapy. The combination also reduced the severity of nausea.

The management of dyspnea in cancer patients: a systematic review

The goal of the study is to evaluate the effectiveness of four drug classes (opioids, phenothiazines, benzodiazepines, and systemic corticosteroids) for relieving dyspnea experienced by advanced cancer patients. A systematic literature review was conducted to July 2006. Search sources included MEDLINE, EMBASE, HealthSTAR, CINAHL, and the Cochrane Library. Four reviewers selected evidence using predefined criteria: controlled trials not limited to cancer and involving the specified drug classes for dyspnea treatment. Three systematic reviews, one with meta-analysis, two practice guidelines, and 28 controlled trials were identified. Most examined the effect of opioids, generally morphine, on dyspnea. Although the results of individual trials were mixed, the systematic review with meta-analysis detected a significant benefit for dyspnea with systemic opioids; two small placebo-controlled trials in cancer patients found systemic morphine reduced dyspnea, and dihydrocodeine also significantly reduced dyspnea in four placebo-controlled trials. Nebulized morphine was not effective in controlling dyspnea in any study or the meta-analysis. No controlled trials examined systemic corticosteroids in the treatment of cancer patients, and of the other non-opioid drugs examined, only oral promethazine, a phenothiazine, showed some benefit in the relief of dyspnea. Studies varied in methodological quality. Systemic opioids, administered orally or parenterally, can be used to manage dyspnea in cancer patients. Oral promethazine may also be used, as a second-line agent if systemic opioids cannot be used or in addition to systemic opioids. Nebulized morphine, prochlorperazine, and benzodiazepines are not recommended for the treatment of dyspnea, and promethazine must not be used parenterally.

A population-based case–control teratologic study of promethazine use during pregnancy

Objective of the study was to investigate the teratogenic effect of oral promethazine, a phenothiazine derivate in the population-based data set of the Hungarian Case–Control Surveillance of Congenital Abnormalities during the years 1980–1996. Of 22,843 cases with 25 congenital abnormalities, 3648 (16.0%) were born to mothers treated orally with promethazine during pregnancy. Of 38,151 matched population controls without congenital abnormalities, 6025 (15.8%) had mothers with promethazine treatment during the study pregnancy. Of 834 malformed controls (Down syndrome), 142 (17.0%) had mothers with treatment of promethazine in the study pregnancy. The case-all matched population controls analysis showed a higher rate of cleft lip ± cleft palate (adjusted OR with 95% CI: 1.5, 1.1–2.0) and poly/syndactyly (OR with 95% CI: 1.3, 1.0–1.8) after promethazine treatment during the 2nd and 3rd months of gestation. However, these risks were explained by recall bias, because these associations were not confirmed after the evaluation of only medically recorded promethazine uses. The comparison of promethazine treatment between 25 congenital abnormality groups and malformed controls did also not show any risk. Thus, the overall evidence from analysis presented did not suggest that clinical doses of promethazine increased the rate of congenital abnormalities in humans.

Delayed bezafibrate‐induced angio‐oedema in a 68‐year‐old man

Delayed bezafibrate‐induced angio‐oedema in a 68‐year‐old man

A comparative study of the haemodynamic effects of atropine and glycopyrrolate at induction of anaesthesia in children

Bradycardia following administration of halothane and suxamethonium in children leads to reduced cardiac output, which can be prevented with prophylactic anticholinergics. Anticholinergics may result in tachycardia and arrhythmias. This study was designed to compare haemodynamic changes and incidence of cardiac arrhythmias following intravenous atropine and glycopyrrolate. Ninety ASA I and II children between one month and twelve years were studied. Premedication was with oral promethazine 1mg/kg. Anaesthesia was achieved with 3 % halothane in 33 % oxygen and nitrous oxide. Patients were randomly allocated to receive atropine 0.01mg/kg (Group I) or glycopyrrolate 0.005mg/kg (Group II). Tracheal intubation was facilitated with suxamethonium 1.5mg/kg. Patients in Group I had a 35.7% rise in heart rate from baseline, compared to 22.5 % in Group II two minutes after anticholinergic administration (p=0.001). Following intubation, heart rate rose by 9.7 % and 13.2 % (p<0.05) in Groups I and II respectively. MAP rose similarly in both groups. Arrhythmia occurred in 44.4 % of patients in Group I and 11.1% in Group II (p=0.001) and were mainly sinus tachycardia. 2.2% of patients in Group I exhibited bigemini. No patient experienced bradycardia. Hypoxia occurred in 2.2 %, hypotension in 13.3% and mild laryngeal spasm in 0% of Group I and 11.1%, 4.4% and 4.4% of Group II respectively. The use of glycopyrrolate compared to atropine, offered better cardiovascular stability in Nigerian children. Arrhythmias occurred more in patients who had atropine and occurred most frequently after tracheal intubation.

Cardiovascular changes during halothane induction in children

The incidence of bradycardia and myocardial depression following halothane induction in children is well documented. Bradycardia leads to reduced cardiac output, which can result in compromised organ perfusion. Halothane may sometimes induce arrhythmia. There is at present no study in this sub-region on the cardiovascular changes of halothane induction in children. This study was designed to investigate the cardiovascular changes and incidence of arrhythmias following halothane induction. Ninety ASA I - II children aged 6 months to 12 years were studied. Premedication with oral promethazine 1mg/kg was given to all patients above the age of one year. Anaesthesia was achieved with incremental halothane up to 3% in 33% oxygen and nitrous oxide. Halothane induction led to a significant drop in SBP, DBP and MAP in all patients at the end of induction. (p < 0.005). Heart rate values were significantly less postinduction in children older than one year (p < 0.05). Arrhythmias occurred in 3.3% of all patients. No patient experienced bradycardia. Other complications included hypotension (8.8% ) and mild laryngeal spasm (2.2% ). Halothane induction in children results in significant reduction in heart rate and blood pressure. Bradyarrhthmias are uncommon with promethazine premedication.