Scopolamine Treatment for Patients With Organophosphate Poisoning
Maneno muhimu
Kikemikali
Maelezo
Objective: to determine whether adding scopolamine to the standard treatment of atropine and oximes improve the outcome of patients with OP poisoning and CNS manifestations. Design: A multi-center, randomized, double blind, placebo controlled study. Setting: Emergency Departments & Intensive Care Units in Israel. Participants: Patients 2 -60 years old with acute OP poisoning and CNS manifestations. Interventions: In addition to standard treatment with atropine and obidoxime, eligible patients will be randomly assigned to one of two treatment groups, scopolamine group, and placebo group (both given in the same volume). Scopolamine will be given IM or IV in a dose of 0.25mg for adults and 0.006mg/kg for children every 4 hours. At least three doses of scopolamine (or placebo) will be given. The medical staff will be blinded to the treatment given. Main outcome measures: Improvement in neurological status, duration of seizures and number of days on ventilator. Data analysis: The main outcome measures, will be compared using the Student's t-test or the Mann-Whitney tests as appropriate. The *2 or Fisher Exact tests, as appropriate, will be used for comparisons of categorical variables. We will use multiple logistic regression to examine the extent to which variables predict success or failure of the treatment.
Tarehe
Imethibitishwa Mwisho: | 02/28/2010 |
Iliyowasilishwa Kwanza: | 10/16/2006 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 10/16/2006 |
Iliyotumwa Kwanza: | 10/17/2006 |
Sasisho la Mwisho Liliwasilishwa: | 04/03/2011 |
Sasisho la Mwisho Lilichapishwa: | 04/04/2011 |
Tarehe halisi ya kuanza kwa masomo: | 09/30/2007 |
Tarehe ya Kukamilisha Utafiti: | 11/30/2009 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Placebo
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Experimental: A IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h | |
Placebo Comparator: B IV Look alike drug Q 4h |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 2 Years Kwa 2 Years |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | Inclusion Criteria: - Age: 2- 60 years - At least two of the following three criteria: - Known exposure to an organophosphate or carbamate insecticide in the last 72 hours. - Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix - Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range ) - CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria Major criteria for CNS involvement: - Seizures - Extrapyramidal or Parkinson like symptoms - Decreased level of consciousness (GCS< 12) Minor criteria for CNS involvement: - GCS 14-12 - Confusion - Hallucinations Exclusion Criteria: - Hypersensitivity to scopolamine - Glaucoma, narrow-angle (angle-closure) - Tachyarrhythmias, congestive heart failure - Obstructive gastrointestinal disease - Myasthenia Gravis - Reflux esophagitis - Ulcerative colitis - Known obstructive uropathy - Pregnancy - Patient or legal guardian unable to give informed consent (see comment under ethics) - Severe co-morbidity (multi-trauma, advanced cancer, etc) |
Matokeo
Hatua za Matokeo ya Msingi
1. Improvement in neurological status as measured by the Glasgow Coma Scale [1 week]
2. Duration of seizures. [1 week]
3. Number of days on ventilator [1 week]
Hatua za Matokeo ya Sekondari
1. Total cumulative dose of atropine [1 week]
2. Need for benzodiazepines [1 week]
3. Number of days in the ICU [2 weeks]
4. Adverse effects and complications [2 weeks]
5. Neurological assessment at discharge [2 weeks]
6. Neurological assessment 3 month after the exposure [3 month]
7. Neuro-cognitive assessment at 3 month [3 month]
8. Survival at 24 hours [24 hours]
9. Survival to discharge [4 weeks]
10. Number of days in hospital [4 weeks]