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PubMed2006

Does cerebral monitoring improve ophthalmic surgical operating conditions during propofol-induced sedation?

Sudden movements from over-sedation during ophthalmic surgery can be detrimental to the eye. Bispectral index (BIS) and middle-latency auditory-evoked potentials (Alaris AEP index, AAI) were reported to be accurate indicators for the level of sedation and loss of consciousness. We assessed these monitors during sedation with special emphasis on preventing over-sedation. One-hundred patients scheduled for elective eye surgery were sedated with target-controlled propofol infusion and randomly allocated to BIS-guided, AAI-guided, BIS/AAI-guided, or clinically guided groups (n = 25 each). The initial target concentration was 0.5 microg x mL(-1) in patients >70 yr and 1.0 microg x mL(-1) in all other patients. The concentration was increased every 3 min by 0.1 or 0.2 microg x mL(-1), respectively until the patient had reached a BIS value of 75 (range 70-90) or an AAI of 40 (range 35-60). The surgeon who was blinded to group allocation assessed treatment quality after the procedure. Sedation was converted into general anesthesia in four patients because of excessive head movements. BIS was out of range 7% of the time vs 58% for AAI. No significant differences in treatment quality were observed among the four groups. We conclude that propofol sedation, guided by BIS or AAI monitoring, did not enhance ophthalmic surgical operating conditions over sedation guided by clinical observation only.

Adolescent↗
PubMed1998

A randomized, prospective, double-blind comparison of midazolam (Versed) and emulsified diazepam (Dizac) for opioid-based, conscious sedation in endoscopic procedures.

OBJECTIVE: We completed a prospective, randomized, double-blinded clinical trial to compare the quality of sedation with two benzodiazepines (emulsified diazepam and midazolam) for endoscopic procedures. METHODS: Adult patients undergoing esophagogastroduodenoscopy or colonoscopy were eligible. Exclusion criteria included: drug allergies, altered mental status, untreated glaucoma, active pancreatitis, hyperlipidemia, resident physician training, or cases done outside the Endoscopy unit. Nurses began the sedation process by administering an opioid followed immediately by administering study drugs until patients were adequately sedated. At completion of the procedure, both the physician and the nurse rated whether the patient's sedation appeared to be adequate. In addition, before discharge, patients were asked to rate the quality of sedation. RESULTS: A total of 111 patients were randomized to the emulsified diazepam group and 100 to the midazolam group. There was no difference in the physician's assessment of quality of sedation between the groups (p > 0.05). The length of time to sedation, total procedure time, and recovery time were similar between both groups. The estimated cost of using emulsified diazepam was approximately 50% less than that of midazolam, with an equal quality of sedation. CONCLUSION: Neither the physicians, nurses, nor the patients could detect a difference between sedation produced by the drugs. We conclude that both drugs were equally effective for sedation for both upper and lower endoscopic procedures. Based on the results of this trial, we suggest that increased use of emulsified diazepam would markedly reduce the cost without altering the quality of sedation. The cost savings would be at least $50,000/yr at our institution.

Adult↗
PubMed2005

Pharmacodynamics of chloral hydrate in former preterm infants.

UNLABELLED: The aim of this study was to document the pharmacodynamics of chloral hydrate in former preterm infants at term post-conception age. The degree of sedation (COMFORT), feeding behaviour and cardiorespiratory events (bradycardic events, apnoeas) before and after administration of chloral hydrate (oral, 30 mg/kg) were prospectively evaluated in former preterm infants during procedural sedation. Characteristics at birth, during neonatal stay and at inclusion were collected. Paired Wilcoxon and McNemar tests were used to study the impact of chloral hydrate. Characteristics of infants who displayed severe bradycardic events were compared to infants in whom no bradycardic events were recorded (Mann Whitney U, Fischer's exact). A significant increase in sedation (decrease COMFORT scale) was observed up to 12 h after administration. There was a minor but significant decrease in oral intake (161 to 156 ml/kg/day, P < 0.01). A significant increase in the number of bradycardic events (<80/min: 38 to 82 events, of which < 70/min: 30 to 79 of which < 60/min: 15 to 45; at least P < 0.01) and in the duration of the most severe bradycardic event (8-12.5 s) was observed. Therefore, further inclusion was stopped when 26 neonates were included. Infants who displayed severe bradycardic (< 60/min) events ( n = 13) after administration of chloral hydrate had a lower gestational age at birth without difference in post-conception age at inclusion. CONCLUSION: Chloral hydrate was associated with an increase in unintended side-effects in former preterm infants, likely reflecting population specific pharmacodynamics and kinetics of chloral hydrate.

Administration, Oral↗
PubMed2003

Pretreatment with intravenous ketamine reduces propofol injection pain.

BACKGROUND: Paediatric procedural sedation using propofol has been shown to be safe and effective and is widely used. Pain at the injection site is a frequent complaint and can be particularly distressing for children, especially for those undergoing repeated procedures. Ketamine has analgesic properties and can diminish the incidence of propofol infusion pain in adults. The aim of the study was to investigate whether pretreatment with ketamine would reduce infusion line pain in propofol sedation in children. METHODS: We performed a prospective, randomized, double-blind trial in a paediatric sedation unit of a tertiary referral teaching hospital. A total of 122 children admitted for gastroscopy were randomly allocated into two groups. Group 1 received atropine and ketamine before propofol infusion. Group 2 received atropine, normal saline solution, and a mixture of propofol with lidocaine. The main outcome measure evaluated was pain associated with the infusion and secondary outcome measures were mean medium arterial pressure decrease and desaturation. RESULTS: The incidence of pain of the infusion was significantly lower in patients pretreated with ketamine (8% vs 37%, P = 0.0001). CONCLUSIONS: Pretreatment with ketamine (0.5 mg.kg-1) is very effective in preventing propofol infusion pain.

Adolescent↗
PubMed1988

The use of flumazenil as an antagonist to midazolam in intravenous sedation for dental procedures.

The efficacy of flumazenil was tested in a double-blind placebo controlled study of 40 patients undergoing dental procedures. Flumazenil recipients were less sedated at 5 and 30 min post-operatively (P less than 0.001), were better oriented at 5 min (P less than 0.001) and 30 min (P less than 0.01) and were more co-operative at 5 min (P less than 0.001) and 30 min (P less than 0.005). None of the patients in either the placebo or flumazenil groups could remember operative events. The dental surgeon felt that flumazenil made recovery in the supine position unnecessary and made post-operative monitoring easier. Flumazenil is a drug that should be included in the armamentarium of any emergency drug kit when benzodiazepines are used i.v.

Adolescent↗
PubMed2005

Intravenous ketamine sedation for painful oncology procedures.

BACKGROUND: The aim of the study was to determine the efficacy and adverse effects of intravenous (i.v.) ketamine sedation administered by nonanesthetist physicians for painful procedures. METHODS: A single-agent, procedural sedation protocol using titrated doses of ketamine i.v. (maximum 2 mg.kg(-1)) was conducted in outpatient pediatric oncology patients undergoing lumbar puncture (LP), bone marrow biopsy/aspiration (BMBx/A) or combination (LP/BMBx/A) in a tertiary care setting. The efficacy of analgesia and sedation (ability to perform the procedure), procedure duration, recovery time and the occurrence of adverse events are described. RESULTS: Fifty-eight subjects of a median age of 5 years (1-13) and median weight of 20 kg (10.5-68) underwent 119 sedations. An LP was performed in 73% of cases, a BMBx/A in 13% and LP/BMBx/A in 13%. Efficacy was 100% and the mean dose of ketamine was 1.3 mg.kg(-1) (0.4). The mean duration of the procedure was 6.6 min (4.2) and the recovery time was 11 min (4-45). Two subjects (1.7%) had a hypoxemia (SpO2 of <94%). No major airway complications occurred. The prevalence of hypertension (systolic > 20% at 5 min) was 54%. The median pain visual analogue score (VAS) for an observer was 0 (range 0-3) and caregiver was 0 (range 0-4). The median VAS for satisfaction (observer) was 10 (range 7-10) and caregiver VAS was also 10 (range 5-10). At 24 h after discharge, the incidence of bad dreams was 3.3%; vomiting, 10.8%; and abnormal behavior, 4.2%. CONCLUSION: Ketamine i.v. up to 2 mg.kg(-1) is an effective sedative for oncology procedures using a defined protocol.

Adolescent↗
PubMed1979

[Sedative measures during surgery on old patients. Result on ocular tension (author's transl)].

An attempt of sedative procedures associated with a locoregional anesthesia was performed on fifty old patients before cataract operation. The blood gases, the blood pressure and the heartrate were measured and the behaviour of the patient just before he awoke was examined to determinate the sedative value. A parallel study revealed a decrease of the intra ocular pressure of 2,5 mm d'Hg due to a slight decrease of the blood pressure and to the effect of the neurolep mixture: the Innovar. This method seems to be very satisfactory in Ophthalmology.

Aged↗
PubMed2006

Consigning "brutacaine" to history: a survey of pharmacological techniques to facilitate painful procedures in children in emergency departments in the UK.

OBJECTIVE: To determine the proportion of emergency departments in the UK that use modern pharmacological methods of pain and anxiety control in children, such as analgesia with intranasal diamorphine, procedural sedation using ketamine or midazolam, and adrenaline-cocaine gel, TAC or LAT for anaesthetising wounds in children. METHODS: A survey UK Emergency Departments conducted by email, post and telephone. RESULTS: Of the 183 (70%) of UK Emergency Departments responding, sedation is achieved using ketamine in 27% and using midazolam in 54%. In 55% of emergency departments intranasal diamorphine is used for analgesia and 41% use at least one of the topical local-anaesthetic mixtures to anaesthetise wounds before suturing. CONCLUSIONS: About half of UK emergency departments use modern pharmacological methods of procedural pain control in children. There is still considerable potential to improve the management of pain in children.

Administration, Intranasal↗
PubMed1996

Approaching a 100% success rate using topical anesthesia with mild intravenous sedation in phacoemulsification procedures.

BACKGROUND AND OBJECTIVES: Phacoemulsification with topical anesthesia has been accepted by some ophthalmologists as a minimally invasive alternative technique for cataract surgery. This study approaches a 100% success rate using topical anesthesia with mild intravenous (i.v.) sedation in phacoemulsification procedures. PATIENTS AND METHODS: Two hundred consecutive patients underwent clear-corneal phacoemulsification. Patients were not preselected. Lidocaine hydrochloride topical anesthesia was supplemented with small-dose i.v. midazolam hydrochloride and/or fentanyl citrate. Patients underwent meticulous preoperative counseling. Those with dementia, deafness, movement disorders, or hyperanxiety, or those who spoke a foreign language or who were young required special management. Additional techniques were employed for ophthalmologic problems such as small pupil, mature cataract, and strong blink/Bell's phenomenon. Patient comfort was noted intraoperatively and postoperatively. RESULTS: Ninety-seven percent of the patients did well, with only 3% requiring regional block or general anesthesia. CONCLUSION: Using nucleofractis phacoemulsification with special techniques in more difficult situations, most patients were successful with topical anesthesia plus i.v. sedative anesthesia.

Administration, Topical↗
PubMed1996

Propofol at conscious sedation doses produces mild analgesia to cold pressor-induced pain in healthy volunteers.

STUDY OBJECTIVE: To determine whether subanesthetic doses of propofol have analgesic effects in healthy volunteers. DESIGN: Prospective, double-blind, placebo-controlled, randomized, crossover trial. SETTING: Human psychomotor performance laboratory within our anesthesia and critical care department. SUBJECTS: 12, non-drug abusing volunteers, aged 22 to 38 years. INTERVENTIONS: Five drug conditions were used in which a loading injection was followed by a 20-minute infusion period: placebo [saline (Intralipid)] injection, Intralipid infusion; propofol 0.125 mg/kg injection, propofol 12.5 mcg/kg/min infusion; propofol 0.25 mg/kg injection, propofol 25 mcg/kg/min infusion; propofol 0.5 mg/kg injection, propofol 50 mcg/kg/min infusion; fentanyl 1.4 mcg/kg injection (positive control), Intralipid infusion. Five minutes into the infusion period and 115 minutes after the infusion period was terminated, subjects immersed their forearms in ice-cold water for three minutes while pain assessments were recorded. MEASUREMENTS AND MAIN RESULTS: Propofol at the two higher doses during part of the first immersion produced a significant reduction (p < 0.05) in pain intensity and bothersomeness ratings. However, relative to fentanyl, the analgesia was mild. Propofol did not affect any ratings on the 15-item short-form McGill Pain Questionnaire, whereas fentanyl reduced 10 of the ratings. CONCLUSION: Our laboratory results are consistent with the commonly accepted clinical practice of supplementing propofol with an opioid in conscious sedation procedures to provide a satisfactory level of pain relief.

Adult↗
PubMed2003

Possible anaphylaxis after propofol in a child with food allergy.

OBJECTIVE: To report a case of anaphylaxis due to propofol in a child with allergies to egg and peanut oil. CASE SUMMARY: A 14-month-old boy with a history of reactive airway disease was hospitalized for treatment of respiratory symptoms. The patient had documented allergies to egg, peanut oil, and mold. Within the first few hours after admission, acute respiratory decompensation occurred, and arrangements were made to transfer the patient to our tertiary-care hospital. Prior to transfer, he was emergently intubated under sedation and paralysis with propofol and rocuronium. When emergency air transport arrived, the patient was hypotensive and tachycardic. His symptoms of anaphylaxis were managed throughout the flight and, upon arrival at our institution, the patient was admitted to the Pediatric Intensive Care Unit. He improved over a 5-day hospital course, and his caregivers were instructed to avoid propofol in the future. The patient's anaphylactic reaction following propofol was rated as a possible adverse drug reaction using the Naranjo probability scale. DISCUSSION: The use of propofol in pediatric patients for procedural sedation has gained increased favor. Since the propofol formulation contains both egg lecithin and soybean oil, its use is contraindicated in patients with hypersensitivities to these components. Several other drugs have a food component, resulting in contraindications and warnings in product labeling. CONCLUSIONS: Propofol should be avoided in patients with allergies to egg and/or soybean oil, if possible. Clinicians should consider the potential for adverse drug events in patients with select food allergies.

Anaphylaxis↗
PubMed2005

Minimum effective dose of midazolam for sedation of mechanically ventilated neonates.

OBJECTIVE: To determine the minimal effective dose (MED) of intravenous midazolam, required for appropriate sedation in 95% of patients, 1 h after drug administration. METHODS: A double-blind dose-finding study using the continual reassessment method, a Bayesian sequential design. Twenty-three newborn infants hospitalized in intensive care unit participated. Inclusion criteria were: (i) post-natal age <28 days, (ii) gestational age >33 weeks, (iii) intubation and ventilatory support required for respiratory distress syndrome, (iv) need for sedation (i.e. one of the six following criteria: agitation or grimacing or crying facial expression before tracheal suctioning, agitation or grimacing or crying facial expression during tracheal suctioning). Each neonate was allocated to a loading dose, ranging from 75 to 200 microg/kg, and a maintenance dose ranging from 37.5 to 100 microg/kg/h. RESULTS: The primary endpoint was the level of sedation 1 h after the onset of infusion. The sedation procedure was classified as a success if all the following clinical criteria were met: no agitation, no grimacing and no crying facial expression before as well as during tracheal suctioning. Based on the 23 patients, the final estimated probability of success was 76.9% (95% credibility interval: 56.6-91.4%) for the 200 microg/kg loading dose. no significant adverse effect was observed. CONCLUSIONS: Continual reassessment is a new approach, suitable for dose-finding study in neonates. this method overcomes some of the ethical, statistical and practical problems associated with this population. Using this method, the MED was estimated to be the 200 mug/kg loading dose of midazolam.

Dose-Response Relationship, Drug↗
PubMed2004

Complicated endoscopic pediatric procedures using deep sedation and general anesthesia are safe in the endoscopy suite.

BACKGROUND: Complicated upper and lower endoscopic procedures of the gastrointestinal tract are performed in children for a variety of diagnostic and therapeutic reasons. Unlike adult patients, who receive conscious sedation, children usually require deep sedation (DS) or general anesthesia (GA). The aim of this study is to assess the safety parameters of complicated endoscopic procedures under DS or GA performed in children in the endoscopy suite rather than in the operating theatre. METHODS: Between May 1997 and December 2002, 296 patients (mean age 4.5 years, range 3 weeks to 16 years), defined as ASA I-III, underwent either DS or GA for endoscopic foreign body extraction, endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous endoscopic gastrostomy (PEG) insertion. ASA physical status I was found in 15%, II in 57% and III in 28%. The pathologies included neuromuscular diseases, genetic syndromes, nesidioblastosis, biliary atresia, hematologic, respiratory (cystic fibrosis) and cardiac disorders. Propofol was the drug of choice (63%) followed by a combination of propofol and midazolam (16%). RESULTS: Transient desaturation (O2 saturation <90%) was the only complication recorded in 21/296 (7.09%) patients. Only two patients with severe respiratory underlying disease were hospitalized for follow-up for a 24-h period. CONCLUSIONS: The use of DS and GA for complicated endoscopies in a moderately high-risk pediatric population was found to be safe. The very low complication rate found in this study suggests that complicated pediatric patients can be managed successfully outside the operating theatre, provided that all the safety criteria for ambulatory DS or anesthesia are present.

Adolescent↗
PubMed2002

A prospective study evaluating the response of patients with unrelieved cancer pain to parenteral opioids.

BACKGROUND: The initiation of continuous parenteral (subcutaneous or intravenous) opioids or a change of opioid (opioid rotation) are treatment options for patients who fail on oral or transdermal opioids. There are insufficient data on the efficacy of these strategies, and comparative data are unavailable. METHODS: The authors prospectively evaluated the efficacy of the start of parenteral opioids in 100 patients with cancer pain who failed on conventional opioids. Pain intensity was rated at rest and during movement from 0 to 10 and was categorized as mild (0-4), moderate (5-6), or severe (7-10): Clinically important pain control was defined as a decrease >or= 2 points in pain intensity and pain intensity < 7. Pain control was evaluated on the second day and again when a clinical decision was made to continue or change parenteral opioid treatment after a median of 6 days. The presence of side effects (absent, mild, moderate, or severe) was evaluated. RESULTS: The mean pain intensity at rest decreased significantly from 6.3 to 4.4 at 48 hours and to 3.4 at the end of treatment. The mean pain intensity during movement decreased significantly from 8.4 to 5.7 at 48 hours and to 4.6 at the end of treatment. Clinically important pain control at rest was seen in 52% of patients at 48 hours, in 71% of patients at the end of treatment; and clinically important pain control during movement was seen in 43% of patients at 48 hours and in 61% of patients at the end of treatment. The proportion of patients with mild pain increased significantly both at rest and during movement. Side effects were present in 78% of patients, and they resolved completely in 32% of patients. The median intravenous morphine equivalent dose increased from 80 mg per day to 135 mg per day at 48 hours and to 201 mg per day at the end of treatment. Results were not different for opioid rotation or for change of route only, nor did the start of antitumour treatment influence the results. In 34% of patients, it was decided to rotate to a second-line parenteral opioid or to start either spinal analgesia or a sedation procedure after a median of 6 days. During follow-up, 18% of patients who were dismissed with parenteral opioids (and 6% of all patients) needed a further change of treatment. CONCLUSIONS: Parenteral opioids improved the balance between analgesia and side effects in patients with cancer pain who failed on conventional opioids, with an important improvement seen in 71% of patients. On the basis of this study, it is concluded that parenteral opioids are a good alternative to spinal opioids. Furthermore, it is suggested that a change of route alone is as effective as opioid rotation.

Adolescent↗
PubMed1994

The subjective, behavioral and cognitive effects of subanesthetic concentrations of isoflurane and nitrous oxide in healthy volunteers.

A prospective, crossover, double-blind trial was conducted in nine healthy volunteers in which the subjective, psychomotor and memory effects of isoflurane (0.0, 0.3 and 0.6%) and nitrous oxide (N2O) (0, 20 and 40%) were examined. Dependent measures included visual analog scales and a standardized drug effects inventory (subjective effects), reaction time and eye-hand coordination (e.g., psychomotor performance), and immediate and delayed free recall (memory). There were some similarities in subjective effects between the two inhaled drugs (e.g., increased ratings of "drunk" and "spaced out"), but isoflurane had effects which N2O did not have. Isoflurane but not N2O increased visual analog scale ratings of "confused," "sedated," and "carefree," and decreased ratings of "in control of thoughts" and "in control of body." An odor was detected with isoflurane and it was disliked. Psychomotor performance was more grossly impaired during isoflurane inhalation than during N2O inhalation. Psychomotor recovery from both agents was rapid and complete so that 5 min after the inhalation period had ceased, performance had returned to baseline levels. Both isoflurane and nitrous oxide impaired immediate and delayed free recall. The feasibility of using isoflurane in conscious sedation procedures is discussed.

Adult↗