[The efficacy of alimemazine (solution for intramuscular injection) in complex with antidepressants in the treatment of anxiety and depressive disorders]. / Otsenka éffektivnosti preparata Alimemazin (rastvor dlia vnutrimyshechnogo vvedeniia) v lechenii trevozhno-depressivnykh rasstroistv.

AIM: To evaluate the efficacy of alimemazine in the form of a solution for intramuscular injections in the treatment of anxiety and depressive disorders. MATERIAL AND METHODS: Twenty patients, who met ICD-10 criteria for anxiety and depressive disorders, participated in the clinical observation. Alimemazine was used in the form of a solution for intramuscular injection (5 mg/ml) along with SSRIs and SNRIs. RESULTS: The significant positive dynamics in the reduction of anxiety-depressive disorders, sleep disorders and vegetative symptoms was observed in patients treated with alimemazine (solution) and antidepressants from the group of SSRIs and SSRIs. CONCLUSION: The drug has demonstrated efficacy and a favorable tolerability profile.

Association between prescribing hypnotics for parents and children in Norway.

OBJECTIVE: To describe the dispensing of the hypnotic alimemazine to children aged 0-3 years and investigate the association between dispensing of alimemazine to children and dispensed hypnotics to their parents. DESIGN: An observational cohort study linking information from the Medical Birth Registry of Norway and the Norwegian Prescription Database. Hypnotics dispensed to parents in a 1-year period before pregnancy was associated with dispensed alimemazine for children aged 0-3 years. PATIENTS AND SETTING: All children born in Norway in 2008 (N=59 325) and their mothers and fathers were included. MAIN OUTCOME MEASURES: Dispensed alimemazine to children during the first 3 years of life. RESULTS: Three percent of children received alimemazine. Dispensed hypnotics to mothers increased the risk of the child receiving a prescription for alimemazine, OR of 2.3 (1.7-3.0) for boys and 1.7 (1.2-2.4) for girls. When both parents had been dispensed prescriptions for hypnotics, the risk increased nearly threefold. A dispensed alimemazine prescription was also associated with dispensed prescriptions for antidepressants to both mother and father, mother's smoking, the child's gender and child's prescriptions for antibiotics, respiratory drugs and dermatological steroids. CONCLUSIONS: Dispensed alimemazine to children under 3 was associated with parents' previous use of hypnotics, indicating that factors other than the child's health influence the use of hypnotic drugs in infancy and toddler years. The frequent usage of alimemazine in children below 3 years and the association with parents' use of hypnotics should concern prescribing doctors.

Sedation for children 2 to 5 years of age undergoing auditory brainstem response and auditory steady state responses recordings.

OBJECTIVE: To evaluate the feasibility, the duration and results of sedation by intrarectal pentobarbital and oral alimemazine for auditory brain stem responses (ABR) and auditory steady-state responses (ASSR) recordings in children aged 2 to 5 years. DESIGN: Prospective study. STUDY SAMPLE: 180 consecutive children aged 2 to 5 years, referred for language retardation and/or behavioral problems, who could not be tested by behavioral methods, underwent ABR and ASSR recordings. The children who did not spontaneously nap were sedated by intrarectal pentobarbital eventually potentiated by oral alimemazine. RESULTS: A spontaneous nap was obtained in only 23 cases, 72 children received only pentobarbital, and 85 received both pentobarbital and alimemazine. Even so, recording was impossible in 16 cases, and interrupted before completion of the ASSR recordings in 45 cases. Children went to sleep in average 64 min +/- 40. The average recording time for the ABR was 20 minutes, and for the ASSR 25 minutes. CONCLUSION: Sedation by pentobarbital, eventually completed by oral alimemazine, allows ABR and/or ASSR recordings in 89.8% of the children who did not nap in the recording room, and is therefore a good alternative to general anesthesia in these children.

One thousand small-bowel biopsies in children. A single-port versus a double-port capsule.

BACKGROUND: Small-bowel biopsy is a well-established technique in the evaluation of children with intestinal malabsorption, e.g. coeliac disease. The biopsy is performed endoscopically or with a peroral capsule instrument. The aim of the present retrospective study was to compare the single-port Watson capsule with the double-port Storz capsule with regard to procedure and fluoroscopy time, complications and failure rate. METHODS: All 1,078 peroral small-bowel biopsies performed at our department during 1989-99 were studied. In 387 of these, the Watson capsule was used and in the remaining 691 the Storz capsule. Median age of the children was 2.5 years. About one-third of the children were premedicated with the prokinetic drug cisapride and as sedatives alimemazine or diazepam orally. Two-thirds of the children were given metoclopramide along with midazolam intravenously. The biopsies were performed under intermittent fluoroscopy. RESULTS: The median biopsy procedure time was significantly shorter with the Storz capsule (7 min) compared to the Watson capsule (10 min) (P < 0.05). The median fluoroscopy time was 5 sec with the Storz capsule and 8 sec with the Watson capsule (P < 0.01). The failure rate did not differ significantly between the two capsule types: 10.3% (Watson) and 7.7% (Storz). One potential but no serious complication occurred. CONCLUSIONS: Providing that effective sedation is available, small-bowel biopsy with a peroral capsule, and the Storz double-port multibiopsy capsule in particular, is a safe and fast method exposing the child to a minimal radiation dose.

A multiple-baseline, double-blind evaluation of the effects of trimeprazine tartrate on infant sleep disturbance.

Infant sleep disturbance involving chronic night waking and resistance to settling to sleep or returning to sleep is a common problem for families with children 6-27 months old. Prescription and nonprescription sedatives are frequently administered without clear evidence that they are effective as either long-term or short-term palliatives. Trimeprazine tartrate, administered either 15 mg/5 mL or 30 mg/5 mL, was compared with both baseline and placebo in a multiple-baseline-across participants, double-blind study. No clinically significant effects of the low dose were detected, whereas the effects of the high dose were not consistently replicated across nor within participants. During active drug treatment, only 2 of 12 children achieved Sleep Behaviour Scale scores indicative of nonproblem sleep. Trimeprazine tartrate is not recommended as a pharmacological treatment for infant sleep disturbance unless as an adjunct to a behavioral therapy program.

A double blind randomized comparison of oral trimeprazine-methadone and ketamine-midazolam for sedation of pediatric dental patients for oral surgical procedures.

The safety and efficacy of an oral sedation technique for children having minor oral surgical procedures under local anesthesia were studied. One hundred healthy children between the ages of 2 and 7 yr received either a combination of midazolam (0.35 mg/kg) and ketamine (5 mg/kg) (Group A), or a combination of trimeprazine (3 mg/kg) and methadone (0.2 mg/kg) (Group B) 30 min preoperatively. Hemodynamic parameters, adverse reactions, postoperative recovery, and behavior were evaluated. More children were asleep, but rousable to verbal commands, 30 min after drug administration in Group A (40%) than in Group B (8%). Immediately before the dental procedure, 46% of children in Group A were asleep in contrast to 8% of children in group B. Significantly more children in Group A were awake, coughing, crying, and moving purposefully 30 and 60 min after admission to the recovery room. Two children (4%) in Group A vomited. Ten (20%) children in Group A hallucinated compared to none in Group B. The surgeon rated the procedure as good or very good in 94% of children in Group A compared to 78% in Group B. Our results show that the combination of midazolam and ketamine, administered orally, is a safe, effective, and practical approach to managing children for minor oral surgical procedures under local anesthesia.

A comparison of midazolam with trimeprazine as an oral premedicant for children.

The effect of oral premedication was investigated in a double-blind, randomised trial in 85 children undergoing tonsillectomy and/or adenoidectomy. Orally administered midazolam 0.5 mg.kg-1 given 30 min pre-operatively was compared with trimeprazine 2 mg.kg-1 given 90 min pre-operatively and a placebo preparation. Compliance, sedation and ease of induction were assessed as were the duration and quality of recovery. Following premedication with midazolam none of the patients was anxious, crying or distressed on leaving the ward, compared with 2/28 in the trimeprazine group and 5/28 in the placebo group (p = 0.0007). More patients were calm and quiet on arrival in the anaesthetic room following midazolam than following trimeprazine, with both premedicant agents comparing favourably with placebo. There was no significant difference between the three groups in the time to recovery or the sedation score on discharge to the ward. Midazolam is a safe and effective oral premedicant for children.

Oral midazolam compared with diazepam-droperidol and trimeprazine as premedicants in children.

Ninety children were assigned randomly to one of three groups for premedication with oral midazolam 0.5 mg.kg-1, diazepam 0.25 mg.kg-1 with droperidol 0.25 mg.kg-1, or trimeprazine 2 mg.kg-1. On arrival at the anaesthetic room, anxiolysis was satisfactory in 26 out of 29 (90%) children who received midazolam compared with 23 out of 29 (79%) who received diazepam-droperidol and 18 out of 29 (62%) who received trimeprazine (P < 0.05); at induction of anaesthesia these proportions were 24 out of 29 (83%), 16 out of 29 (55%) and 11 out of 29 (40%) respectively (P < 0.001). When individual groups were compared, anxiolysis was significantly greater in the midazolam group compared with the trimeprazine group on arrival in the anaesthetic room (P < 0.05) and significantly greater in the midazolam group than in either the diazepam-droperidol or the trimeprazine groups at induction of anaesthesia (P < 0.05 and P < 0.001 respectively). There were no significant differences in times to early recovery between the groups (25.4, 24.4 and 28.5 min). Analysis of behavioural questionnaires completed two weeks after hospitalization showed a trend towards fewer postoperative behavioural disturbances in children who received midazolam or diazepam-droperidol compared with trimeprazine (47 and 44% vs 75%); when the results for the benzodiazepine-containing premedicants were combined, the difference between these groups and trimeprazine was statistically significant (P < 0.05).

Oral premedications in paediatric day surgery.

The degree of sedation in 191 day-stay children after oral premedication were compared. One hundred and forty-six were 1-5 years old (Group 1) and were randomised to receive either chloral 40 mg/kg, midazolam 0.2 mg/kg, promethazine 1 mg/kg, trimeprazine 3 mg/kg or placebo. Forty-five were 5-12 years old and were randomised to receive either trimeprazine 3 mg/kg, midazolam 0.2 mg/kg or placebo (Group 2). The children were assessed using four categories: asleep or drowsy, awake but calm, crying or anxious and oversedated or obstructed airway. They were assessed on leaving the ward, at separation from the parents, at induction, in the recovery room and one and two hours after returning to the ward. In Group 1, it was found that chloral and trimeprazine gave the best degree of sedation but the sedative effect of trimeprazine lasted longer into the post operative period. In Group 2, it was found that the children did not require deep sedation and the anxiolysis obtained with midazolam was adequate.

Oral versus intravenous premedication for small bowel biopsy in children: effect on procedure and fluoroscopy times.

Oral alimemazine and cisapride, or diazepam and cisapride, or iv midazolam and metoclopramide were given as premedication for small bowel biopsy to three groups of children from a total population of 185 individuals. The biopsy procedures were performed under intermittent fluoroscopy and times for both were recorded. The median biopsy procedure time was significantly shorter in children given iv midazolam and metoclopramide (6 min) compared to those given oral premedication (10 min) (p < 0.001). The median fluoroscopy time was very short in all groups, ranging between 3 and 6 s. It is concluded that iv premedication is superior to oral premedication for small bowel biopsy in children because more effective sedation is obtained.

Behavioural changes in children following minor surgery--is premedication beneficial?

One hundred and twenty-three male children, aged one to ten years, were studied to determine the influence of premedication on changes in patterns of behaviour following hospitalization for repair of inguinal hernias. Four comparable groups were selected for premedication regimen: (1) A control group without premedication; (2) oral trimeprazine tartrate 2 mg/kg, methadone 0.1 mg/kg and droperidol 0.15 mg/kg; (3) oral midazolam 0.45 mg/kg; (4) intramuscular midazolam 0.15 mg/kg. Standard inhalational anesthesia was used and caudal blocks employed for analgesia. The parents returned a questionnaire at two weeks. Changes in behaviour were reported in 78% of the children and overall, premedication showed little benefit. However, midazolam premedication was associated with a significantly lower incidence of night-time crying and awakening, compared with no premedication. Only for night-time crying and day-time toilet training did age below five years prove to be a significant contributing factor.

Treatment of infant sleep disturbance by trimeprazine in combination with extinction.

Chronic sleep disturbance is a common problem in preschool children. Prescription and non-prescription sedatives provide short-term palliative relief. Behavioral extinction by withdrawal of parental attention is enduringly effective but may be distressing short-term because of postextinction bursts of intense activity by the child. This study evaluated the effects of combining extinction and sedative medication (trimeprazine tartrate), prescribed in a reducing dose over the first 10 days of extinction. Control groups received either extinction alone or a placebo administered double-blind. After baseline, all subjects reduced their sleep disturbance to low levels, the extinction and placebo groups declining slowly, the medication group abruptly. These gains were maintained at follow-up. Measures of infant security and maternal anxiety showed improvements with treatment.

Oral midazolam in paediatric premedication.

In a premedication study involving 135 children, aged 1-10 years, four regimens were investigated: (i) no premedication; (ii) oral trimeprazine tartrate 2 mg/kg, methadone 0.1 mg/kg, droperidol 0.15 mg/kg (TMD); (iii) intramuscular midazolam (Dormicum; Roche) 0.15 mg/kg; and (iv) oral midazolam 0.45 mg/kg. All premedications were given 60 minutes before a standard halothane anaesthetic. No impairment of cardiovascular stability occurred but after premedication the mean oxygen saturation decreased by 1.6% and 1.1%, respectively, in the intramuscular midazolam and TMD groups. Overall, children under 5 years of age behaved less satisfactorily in the holding room and at induction, than those over 5 years (P less than 0.01). Midazolam, intramuscularly and orally, produced more satisfactory behaviour than the other two regimens (P less than 0.05) and, combined with a 70% more rapid recovery than the TMD regimen (P less than 0.05), suggests that oral midazolam is a more effective paediatric premedication agent than placebo or TMD.

Midazolam and amnesia in pediatric premedication.

One hundred and twenty-eight children aged three to ten years, were studied to determine the effect of premedication on amnesia for the preanesthetic period. Four comparable groups were used: A control group, no premedication; oral trimeprazine tartrate 2 mg/kg, methadone 0.1 mg/kg plus droperidol 0.15 mg/kg (T.M.D.); oral midazolam 0.45 mg/kg; intramuscular midazolam 0.15 mg/kg. Amnesia was tested for four pictorial facts, and for induction of anesthesia. For pictorial facts, both routes of midazolam administration gave a sixty percent incidence of amnesia compared with sixteen percent in the control group (p less than 0.001). The T.M.D. premedication provided a forty-three percent incidence, also better than the control group (p less than 0.05). Induction was remembered by fifty percent of the midazolam children compared with sixty-six percent of the T.M.D. group (p greater than 0.05) and eight-one percent of the control group (p less than 0.05). The potential advantages of amnesia in pediatric premedication are discussed.

Trimeprazine as oral premedication in children.

The effect of oral trimeprazine alone or in combination with either atropine or glycopyrrolate or pethidine as oral premedication in children was studied. The effects of different drug combinations were evaluated in respect of pre-operative sedation, salivary secretion, induction characteristic, postoperative sedation and postoperative vomiting. The study concludes that trimeprazine in combination with either atropine or glycopyrrolate is mostly effective, safe and satisfactory as oral premedication in children. Trimeprazine along with pethidine can be recommended for all purpose oral medication both in pre- and post-operative period.

Sedation in children scanned with high-field magnetic resonance; the experience at the Hospital for Sick Children, Great Ormond Street.

Patient movement is the most common cause of image degradation when performing magnetic resonance scans in children. This is a particular problem scanning at high field, as noise levels of up to 90 dB may be reached. Movement can be reduced by adequate sedation. We present the results of two sedation protocols when scanning with a 1.5T Magnetom scanner. Optimal scan quality can be achieved in up to 85% of scans using Pethco combined with triclofos in children aged 1 month-2 years, and trimeprazine combined with papaveretum in children over 2 years. When heavy sedation is used, patient selection must be cautious, and there is a minimum acceptable level of monitoring including close physical observation, electrocardiographic and apnoea monitoring.